Prospective Double-blind Study Research Articles

Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block Combined with Port-Site Infiltration (PSI) for Laparoscopic Sleeve Gastrectomy in an ERABS Pathway: A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial.

Patients undergoing laparoscopic sleeve gastrectomy (LSG) commonly experience moderate to severe postoperative pain. We conducted a randomized, prospective double-blind placebo-controlled study to evaluate the analgesic effect of laparoscopic-guided TAP (LG-TAP) block after LSG in a high-volume bariatric center, applying an enhanced recovery after bariatric surgery (ERABS) pathway. One hundred ten patients were randomly allocated to receive LG-TAP block with local anesthetic (LA) or saline solution (placebo), both combined with port-site infiltration with LA (LA-PSI). Primary outcome was pain score measured in post-anesthesia care unit (PACU) and at 6, 12, and 24 h after surgery. Secondary outcomes included postoperative nausea and/or vomiting (PONV), analgesic requirement, time to walking, time to flatus, length of hospital stay (LOS), and surgical complications. No significant differences were observed between LG-TAP and placebo groups in postoperative analgesia, with a median (IQR) NRS of 2 (4.75-0) vs. 2 (5.25-0) in PACU, 5.5 (7-3) vs. 6 (7-4) at 6 h, 2 (6-0) vs. 3 (5.25-1.75) at 12 h, and 2 (3.75-0) vs. 1 (2-0) at 24 h; all p > 0.05. A significant difference was found in PONV in PACU (LG-TAP, 46%; placebo, 25%, p-value, 0.019) and at 6 h postoperatively (LG-TAP, 69%, placebo, 41%, p-value, 0.003). No differences were observed as regards other secondary outcomes. Our results suggest that LG-TAP block is not related to more effective postoperative analgesia compared to placebo when LA-PSI is performed.

Monitored anesthesia care: Dexmedetomidine-ketamine versus dexmedetomidine-propofol combination during burr-hole surgery for chronic subdural hematoma: A randomized trial

Background and Aim: Selecting the ideal drug combination for effective monitored anesthesia care to keep patients comfortable and safe during evacuation of chronic subdural hematoma is a challenge. Our hypothesis was that the combination of dexmedetomidine with ketamine might provide safer monitored anesthesia care keeping airway patency and stable hemodynamics in comparison to dexmedetomidine-propofol combination during burr-hole surgery for evacuating chronic subdural hematoma in high-risk patients.Methods: A total of 56 paticipants were allocated into two groups in this randomized prospective double-blind study by a computer-generated randomization table. DK group (n = 28): Patients were given a mix of ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg) diluted in 10 ml of saline solution infused over 10 min as an intravenous bolus dose. This was followed by a continuous infusion of 0.5 µg/kg/h dexmedetomidine with 0.5 mg/kg/h ketamine. DP group (n = 28): Patients were given a mix of propofol (0.5 mg/kg) and dexmedetomidine (1 µg/kg) diluted in 10 ml of saline solution infused over 10 min as an intravenous bolus dose. This was followed by a continuous infusion of 0.5 µg/kg/h dexmedetomidine with 0.5 mg/kg/h propofol. The infused solutions were in two separate syringe pumps. The target was to achieve a modified Observer's Assessment of Alertness and Sedation score (OAA/S) of 3, and the infusion was stopped by finishing the skin suture.Results: The onset of sedation using OAA/S was significantly longer in the DK group (413.21 ± 49.18 s.) compared to (297.21 ± 37.68 s.) in the DP group. The number of participants with an airway obstruction score of 1 and 2 was significantly higher in the DK group compared to the DP group; however, those with a score of 3 were significantly higher in the DP group. The total number of patients needing intraoperative fentanyl was comparable between groups. The number of patients who developed intraoperative hypotension, bradycardia, bradypnea, and hypoxemia was significantly higher in the DP group compared to the DK group (p < 0.05). There was an improvement in postoperative Markwalder's Neurological Grading Scale (MNG) scores compared to preoperatively in both the DK and DP groups. The recovery time was significantly longer in the DK group (8.75 ± 1.17 min) compared to (5.73 ± 0.75 min) in the DP group, with comparable surgeon satisfaction.Conclusions: Combining dexmedetomidine with ketamine is safer than dexmedetomidine with propofol for effective monitored anesthesia care in high-risk patients undergoing burr-hole surgery for evacuating chronic subdural hematoma.Institutional Review Board approval (ref: 6434/25-10-2020).ClinicalTrials.gov (ref: NCT04621526, the date of registration: 9-11-2020).

Comparison of channelled with non-channelled blade of King Vision videolaryngoscope for orotracheal intubation in patients undergoing emergency surgery: A randomised double blind study

BackgroundPatients undergoing emergency surgery can have both anatomical and physiological difficult airways. There being no consensus on the best strategy to secure such airways, hence the present study evaluated the clinical performance of the two blades of King Vision™ Videolaryngoscope (KVVL). MethodsThis prospective double blind study was done on fifty two patients of 18–80 years aged posted for emergency surgery under general anaesthesia (GA). Patients were randomly assigned to channelled (CH) and non-channelled (NC) group for intubation. The primary outcome was time to tracheal intubation with CH and NC blades. The secondary outcomes among the two groups noted were ease of videolaryngoscope (VL) blade insertion, time to optimal laryngeal view, fremantle score, number of intubation attempts, any manoeuver required to intubate and complications. Haemodynamic parameters were noted before induction, during preoxygenation before laryngoscopy and 5 min after endotracheal intubation. ResultsSignificant shorter time to intubation was noted in NC group (18s) compared with CH group (25s). The NC blade was easier to insert and the time to optimal laryngeal view was also shorter with NC group (7s) as compared to CH group (10s). Fremantle score was comparable among the two groups. Endotracheal tube (ETT) impingment on arytenoids was more common with NC blade. For intubation with CH blade, anticlockwise rotation of ETT was frequently required. ConclusionThe NC blade of KVVL was easier to introduce and resulted in faster intubation, thus favouring its use in patients undergoing emergency surgery under GA. The CH blade of KVVL required anticlockwise rotation to facilitate intubation.

Assessing acute nicotine impact on choroidal thickness: a randomized, double-blinded study comparing smoking cessation aids, including nicotine gum and electronic cigarettes.

To explore whether differences in choroidal thickness arise from nicotine consumption in healthy young individuals, specifically comparing the effects of nicotine gum to electronic cigarette (vaping), while maintaining a consistent 4mg nicotine dosage. In a randomized double-blinded prospective cross-sectional study, 20 healthy participants (mean age ± standard deviation: 23 ± 2.36years) were randomly assigned to either the nicotine gum or vaping group. Choroidal thickness (ChT) measurements were conducted using optical coherence tomography (OCT) (Topcon 3D OCT-1 Maestro System) at baseline, 30, and 60min after ingesting 4mg of nicotine, with ChT measurements taken from five different horizontal areas. Neither the nicotine delivery method (gum or vaping) demonstrated a statistically significant impact on ChT mean scores among subjects in the five measured areas at baseline, 30, and 60min (p > 0.05). However, significant differences were observed in ChT mean scores within subjects across the five areas (F (1.83, 72) = 36.43, p < 0.001), regardless of other study factors such as group, time, and visit (p > 0.05). A statistically significant interaction was identified between the factors of area and time concerning participants' ChT mean scores when stratified by the type of smoking (tobacco, vaping, and dual) (p = 0.003). The results of this study revealed that nicotine, up to particular concentration of 4mg, does not have a statistically significant vasoconstrictive effect on choroidal thickness, regardless of the delivery method, within the examined group. These findings offer valuable insights into the relationship between nicotine intake and choroidal dynamics in young adults.

A Prospective Double-Blinded Comparison of Reflectance Confocal Microscopy with Conventional Histopathology for In Vivo Assessment in Oral Cancer.

We investigated reflectance confocal microscopy (RCM) as a possible non-invasive approach for the diagnosis of cancer and real-time assessment of surgical margins. In a phase I study on 20 patients, we established the RCM imaging morphological features that distinguish OSCC from normal tissue with a newly developed intra-oral RCM probe. Our subsequent phase II prospective double-blinded study in 60 patients tested the diagnostic accuracy of RCM against histopathology. Five RCM videos from the tumor and five from normal surrounding mucosa were collected on each patient, followed by a 3-mm punch biopsy of the imaged area. An experienced RCM reader, who was blinded to biopsy location and histological diagnosis, examined the videos from both regions and classified each as "tumor" or "not-tumor" based on RCM features established in phase I. Hematoxylin and eosin slides from the biopsies were read by a pathologist who was blinded to RCM results. Using histology as the gold standard, we calculated the sensitivity and specificity of RCM. We report a high agreement between the blinded readers (95% for normal tissue and 81.7% for tumors), high specificity (98.3%) and negative predictive values (96.6%) for normal tissue identification, and high sensitivity (90%) and positive predictive values (88.2%) for tumor detection. RCM imaging is a promising technology for non-invasive in vivo diagnosis of OSCC and for real-time intraoperative evaluation of mucosal surgical margins. Its inherent constraint, however, stems from the diminished capability to evaluate structures located at more substantial depths within the tissue.

Comparison of Magnesium Pre-treatment With Two Different Doses of Rocuronium in Rapid Sequence Intubation: A Randomized Controlled Trial.

Introduction Magnesium is recognized for its ability to reduce the onset time of rocuronium while simultaneously extending its duration of action. This study aims to assess the efficacy of magnesium pre-treatment in decreasing the onset time with two different doses of rocuronium in patients undergoing rapid sequence intubation. Materials and methods This randomized prospective double-blind clinical study involved 50 patients classified as American Society Of Anesthesiologists (ASA) I/II, with no preoperative indications of difficult intubation, undergoing elective surgery under general anesthesia. The patients were divided into two groups: group A received 60 mg/kg of magnesium 15 minutes before intubation with 1.2 mg/kg of rocuronium, and group B received 60 mg/kg of magnesium before 0.6 mg/kg of rocuronium. Intubating conditions were assessed and graded at loss of last twitch after administration in both groups, considering ease of intubation, vocal cord position, and response to the insertion of the tracheal tube. Simultaneously, hemodynamic variations were recorded just before intubation, at one minuteand five minutes post-intubation. Results Intubating conditions with 0.6 mg/kg of rocuronium were comparable or equally good compared to 1.2 mg/kg of rocuronium with magnesium pre-treatment. Conclusions Magnesium pre-treatment enhances the neuromuscular blocking effect of rocuronium, reducing its onset time without clinically significant prolongation of the duration of the block.

Effect of corticosteroids on ischemia-reperfusion injury of deep inferior epigastric perforator flap after re-exploration for anastomosis thrombosis: A prospective randomized trial

Patients undergoing breast reconstruction with the deep inferior epigastric perforator (DIEP) flap are at risk of arterial and venous thrombosis, necessitating flap salvage surgery. However, this carries the risk of ischemia-reperfusion injury (IRI) and potential significant partial or complete flap loss. The objective of this study was to evaluate the potential benefit of corticosteroids in reducing IRI related complications in DIEP flaps that are returned to the operation theater for attempted salvage after venous or arterial failure.A double-blinded prospective randomized study was conducted between January 2012 and January 2023 on patients scheduled for secondary unilateral breast reconstruction using the DIEP flap technique. Patients were included if they developed post-operative venous or arterial flap thrombosis and experienced DIEP flap IRI following operative take-back and anastomosis revision. The treatment group (TG) received a 5-day course of corticosteroids, while the control group (CG) did not receive any specific treatment. Forty-six patients were enrolled in the study. In the CG, two cases of total flap loss and eight cases of partial flap necrosis were observed, while the TG had only 1 case of partial flap necrosis (p < 0.05). The complete resolution of clinical signs of IRI occurred within 13 ± 2.1 days for the TG and 21 ± 3.5 days for the CG (p = 0.00001). The TG had a significantly shorter hospital stay (11.13 ± 0.38 days) compared with the CG (15.47 ± 1.27 days; p < 0.0001). Targeted corticosteroid therapy following a salvage procedure for vascular thrombosis in DIEP flaps has shown promise as an effective treatment for subsequent IRI. This approach may be considered as a viable option for managing IRI in free flaps. However, further studies involving a larger number of patients are required to substantiate our hypothesis.

Comparative evaluation of simvastatin gel in enhancing peri-implant osteoblastic activity during the Osseo integrative phase using Bone scintigraphy: A prospective case-control double blinded study.

Simvastatin (SMV), a lipid lowering drug, can modulate the process of bone regeneration at the molecular and cellular levels. Its effect on the osseointegration of implants has been studied extensively on animals with assuring results with limited research on human subjects. To estimate the effect of simvastatin gel in the osseointegration of dental implants using bone scintigraphy, Materials and Methods: 20 participants with missing mandibular first molars and D2 type bone were assigned equally to Group A receiving 1.2% simvastatin and Group B receiving Placebo gels during the placement of implants. The participants were subjected to bone scintigraphy to determine the osteoblastic activity at baseline, 30th day and 90th day after implant placement. Group A revealed a significant increase in osteoblastic activity between baseline, day 30 and 90 (P<.05) with a higher mean of 100.06±21.644% on day 30. Group B revealed a significant increase in osteoblastic activity only between baseline and day 30, and baseline and day 90 (P<.05) whereas there was no difference between day 30 and 90 (P>.05) with a higher mean of 79.20±18.255% on day 30. Bivariate analysis at different time periods revealed a significant difference between groups A and B on day 30. Implants placed with 1.2% simvastatin gel showed enhanced osteoblastic activity on the fourth week of implant placement, indicating faster rate of osseointegration at an early stage.

Effect of CoQ10 Addition to Rectal Indomethacin on Clinical Pancreatitis and Related Biomarkers in Post-endoscopic Retrograde Cholangiopancreatography

Background: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most prevalent complication of ERCP. Oxidative stress has been mentioned as a cause of PEP. Objectives: As preclinical and clinical studies have shown that CoQ10 has anti-inflammatory and antioxidant effects, the present study was designed to examine whether oral CoQ10 addition to rectal indomethacin decreases the rate/severity of PEP. Methods: A prospective double-blind clinical study was done on 347 patients undergoing ERCP. All participants received 100 mg rectal indomethacin just before ERCP. Also, patients were asked to consume CoQ10 (200 mg) or an identical placebo for 1 h before the procedure. The occurrence and severity of PEP were determined in the participants. The levels of amylase, lipase, and malondialdehyde (MDA) were also measured 12 h after ERCP. Results: The total rate of PEP was equal to 12.1% in intention-to-treat (ITT) and 13% in per-protocol (PP) analyses. A meaningful difference was observed in the rate and severity of PEP between the CoQ10 and placebo arms (9.8% vs 14.4% in ITT and 10.2% vs 15.1% in PP, sequentially). Secondary levels of amylase, lipase, and MDA were lower in the CoQ10 arm than in the placebo arm (P = 0.032, 0.022, and 0.036, sequentially). Conclusions: A combination of oral CoQ (200 mg) plus rectal indomethacin (100 mg) could decrease the PEP rate and severity meaningfully compared to the use of indomethacin alone.

A comparative evaluation of the effect of addition of 8 mg dexamethasone to 2% lignocaine with adrenaline in mandibular third molar surgery: a split mouth randomised double blind study.

Impacted lower third molar surgeries involve trauma in a highly vascularized zone with loose connective tissue leading to inflammatory sequelae including postoperative pain, swelling, trismus and generalised oral dysfunction during the post-operative phase. In minor oral surgical procedures, an all-inclusive method to protract anaesthesia and reduce the inevitable post-operative sequelae is yet to be explored substantially. To evaluate the efficacy of dexamethasone added to local anaesthetics in extending the depth and duration of anaesthesia and decreasing the postoperative complications after surgical removal of impacted third molars. A controlled, randomized, split-mouth, double-blind prospective study involving lower third molar surgery was performed in 35 patients wherein the test group (Group I) received 8 mg dexamethasone added to 2 ml of 2% lignocaine with epinephrine and the control group (Group II) received 2 ml of sterile water added to 2 ml of 2% lignocaine with epinephrine. Onset and duration of anaesthesia were evaluated; followed by evaluation of pain, swelling and trismus for 7 days post-surgery, using independent t-test and ANOVA for repeated measures. Test group had a faster onset of anaesthesia by 69 s and a lengthier duration of 128.4 min (p < 0.001). Pain scores (Visual Analogue Scale) in the first 24 h were 4.9 and 7.5 in the test and control group respectively (p < 0.001). The average dosing of analgesics until postoperative day 7 in the test and control group were 12.6 and 18.4 respectively (p < 0.001). The swelling was significantly lesser in the test group, in addition, trismus was significantly lesser by 1 cm on postoperative days 1 and 2 and 0.2 cm on day 7. The addition of dexamethasone to lignocaine in the nerve block reduces the time of onset and significantly prolongs the duration of anaesthesia with decreased pain, swelling and trismus. Steroids mixed directly with the local anaesthetic agent can minimise the post-operative sequelae associated with third molar surgery with a single needle prick.

The value of lung ultrasound score in neonatal respiratory distress syndrome: a prospective diagnostic cohort study.

The accurate diagnosis of critically ill patients with respiratory failure can be achieved through lung ultrasound (LUS) score. Considering its characteristics, it is speculated that this technique might also be useful for patients with neonatal respiratory distress syndrome (NRDS). Thus, there is a need for precise imaging tools to monitor such patients. This double-blind randomized cohort study aims to investigate the impact of LUS and related scores on the severity of NRDS patients. This study was conducted as a prospective double-blind randomized study. Bivariate correlation analysis was conducted to investigate the relationship between LUS score and Oxygenation Index (OI), Respiratory Index (RI), and Sequential Organ Failure Assessment (SOFA) score. Spearman's correlation coefficient was used to generate correlation heat maps, elucidating the associations between LUS and respective parameters in different cohorts. Receiver Operating Characteristic (ROC) curves were employed to calculate the predictive values, sensitivity, and specificity of different scores in determining the severity of NRDS. This study ultimately included 134 patients admitted to the intensive care unit (ICU) between December 2020 and June 2022. Among these patients, 72 were included in the NRDS cohort, while 62 were included in the Non-NRDS (N-NRDS) cohort. There were significant differences in the mean LUS scores between NRDS and N-NRDS patients (p < 0.01). The LUS score was significantly negatively correlated with the OI (p < 0.01), while it was significantly positively correlated with the RI and SOFA scores (p < 0.01). The correlation heatmap revealed the highest positive correlation coefficient between LUS and RI (0.82), while the highest negative correlation coefficient was observed between LUS and OI (-0.8). ROC curves for different scores demonstrated that LUS score had the highest area under the curve (0.91, 95% CI: 0.84-0.98) in predicting the severity of patients' conditions. The combination of LUS and other scores can more accurately predict the severity of NRDS patients, with the highest AUC value of 0.93, significantly higher than using a single indicator alone (p < 0.01). Our double-blind randomized cohort study demonstrates that LUS, RI, OI, and SOFA scores can effectively monitor the lung ventilation and function in NRDS. Moreover, these parameters and their combination have significant predictive value in evaluating the severity and prognosis of NRDS patients. Therefore, these results provide crucial insights for future research endeavors.

Comparative study between rocuronium and magnesium sulfate as adjuvants to local anesthetics for peribulbar block

Background &amp; Objective: Peribulbar anesthesia is frequently used in cataract surgeries. Compared to retrobulbar anesthesia, this approach is associated with less significant consequences. However, the prolonged onset of orbital akinesia and the frequent need for block replenishment are considered drawbacks. We aimed to investigate the impact of adding rocuronium and magnesium sulfate to a commonly used local anesthetic combination on the onset of corneal anesthesia and the degree of lid and globe akinesia during peribulbar block in ocular surgeries.&#x0D; Patients and Methods: This prospective double-blinded randomized study was conducted in the ophthalmic surgery operating theater, Ain Shams University Hospital from January 2019 to April 2020. We enrolled 75 patients from both sexes, with American Society of Anesthesiology (ASA) physical status I–III, ages 40-80 y, and an axial globe length less than or equal to 26 mm planned for cataract surgery under peribulbar block in the study following institutional ethical board approval and written informed patient consents. Patients were randomly divided into three groups, 25 patients per group, based on the drugs they received: Group O (control group): received local anesthetic + 0.9% normal saline (1 ml). Group M: received local anesthetic + magnesium sulphate 50 mg in normal saline. Group R: received local anesthetic + rocuronium at a dose of 0.06 mg/kg (maximum 5 mg) in normal saline.&#x0D; Results: Our study found statistically significant more rapid onset of action (mean time to start surgery) in rocuronium group (7.00 ± 1.22 min) than control group and magnesium sulfate group (9.00 ± 1.47 and 9.00 ± 1.15 min) respectively, (P &lt; 0.001); Moreover, no significant difference was noted between control group and magnesium sulfate group. In addition, no relevant difference was reported regarding duration of surgery between the groups.&#x0D; Conclusion: During cataract surgery, the addition of rocuronium to the local anesthetic mixture in the peribulbar nerve block has been found to enhance ocular akinesia and corneal anesthesia. Furthermore, the use of rocuronium demonstrated a significantly faster onset and shorter time needed to achieve the appropriate conditions to initiate the surgical procedure compared to the use of magnesium sulfate. Addition of magnesium sulfate showed good results regarding akinesia, corneal anesthesia and need for supplementary injections but it did not significantly fasten the onset of block and hence the time to start surgery.&#x0D; Key words: Cataract; Magnesium Sulfate; Peribulbar Block; Rocuronium&#x0D; Citation: Nagy M, Abo El-Ella S, El-Shafey MA, Helal AM, Zekry MR. Comparative study between rocuronium and magnesium sulfate as adjuvants to local anesthetics for peribulbar block. Anaesth. pain intensive care 2024;28(1):55−61; DOI: 10.35975/apic.v28i1.2157&#x0D; Received: February 18, 2023; Reviewed: July 30, 2023; Accepted: December 23, 2023

Comparative Study of Ropivacaine Alone Versus Combination of Ropivacaine with Either Dexmedetomidine or Dexamethasone for Ultrasound Guided Supraclavicular Brachial Plexus Block

Background: Ropivacaine is a common choice for supraclavicular brachial plexus block. Dexmedetomidine and Dexamethasone are frequently added to local anesthetics for improved effects. With limited comparative evidence, this study aimed to assess Dexmedetomidine and Dexamethasone as adjuvants to Ropivacaine in ultrasound-guided supraclavicular brachial plexus block.Methods: This prospective double-blind study enrolled patients aged 18-60, scheduled for elective upper limb surgery below mid-humeral level. They were randomly assigned into three groups: Ropivacaine alone, Ropivacaine with Dexmedetomidine (1 mcg/kg), or Ropivacaine with Dexamethasone (8 mg). The study aimed to compare sensory and motor blockade onset and duration, postoperative analgesia duration, and adverse event occurrence among the groups.Results: Ninety-eight patients participated in the study. All three groups showed similar characteristics in terms of age, weight, gender, ASA grade, and surgery duration. The onset and duration of sensory and motor block were comparable between the Dexamethasone and Dexmedetomidine groups. A significant difference was observed when comparing the Ropivacaine only group to either of the other two groups or when comparing all three groups. Similarly, postoperative analgesia duration was comparable between the Dexamethasone and Dexmedetomidine groups while it differed significantly when comparing all three groups or when comparing the Ropivacaine only group to either of the other groups. Ropivacaine with Dexmedetomidine group experienced notable occurrence of bradycardia.Conclusion: Dexamethasone and Dexmedetomidine as adjuvants to 0.5% Ropivacaine for ultrasound-guided supraclavicular brachial plexus blockade have comparable effects on sensory and motor blockade onset and duration, along with postoperative analgesia duration. Dexmedetomidine, however, is linked to more bradycardia compared to Dexamethasone.

Artículo traducido] Tratamiento comparativo de lesiones mucocutáneas en pacientes con telangiectasia hemorrágica hereditaria con láser dual secuencial de colorante pulsado y neodimio: itrio-aluminio-granate versus neodimio: itrio-aluminio-granate solo: un estudio controlado aleatorizado doble ciego con evaluación de la calidad de vida

BackgroundHereditary haemorrhagic telangiectasia (HHT) is characterized by the presence of telangiectases and larger arteriovenous malformations in different organs. Mucocutaneous telangiectases can bleed and become an aesthetic concern, impairing quality of life (QoL). However, the best treatment approach has not been defined yet. ObjectiveTo evaluate the efficacy and safety of dual wavelength sequential 595/1064nm laser (DWSL) compared to 1064nm laser (Nd:YAG) alone. Secondarily, to evaluate QoL impairment in HHT patients, and its improvement with laser therapy. MethodsA comparative randomized split-body double-blinded prospective study (DWSL vs Nd:YAG). Demographic, clinical and treatment characteristics were recorded. The severity and degree of improvement were evaluated by three blinded examiners who scored pre-treatment and post-treatment pictures on a 5-point scale. Patients fulfilled Skindex-29 and FACE-Q® tests and assessed procedure-associated pain and patient satisfaction. Results111 treatment areas (55 treated with DWSL and 56 with Nd:YAG) from 26 patients were analyzed. The median number of laser sessions was 2 (interquartile range [IQR] 2–4; mean 2.90 vs 2.88, respectively). The median improvement score, irrespective of location, was significantly higher for Nd:YAG compared to DWSL: 3 (IQR 2–3; mean 2.61) vs 2 (IQR 2–3; mean 2.32), p=0.031. Both FACE-Q index and Skindex-29 test results improved significantly (p<0.001), and 92.4% patients reported a high degree of satisfaction (≥8). No severe adverse events were reported. ConclusionsDWSL and Nd:YAG laser are convenient, safe and effective treatment options for mucocutaneous telangiectases in HHT patients. However, Nd:YAG delivered better results with better tolerability. QoL was significantly improved by both treatments.

Effect of bone marrow aspiration concentrate and platelet-rich plasma combination in anterior cruciate ligament reconstruction: a randomized, prospective, double-blinded study

BackgroundThe effect of bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) combination in enhancing graft maturation and tendon–bone tunnel interfacial healing after anterior cruciate ligament (ACL) reconstruction remains unclear. We hypothesised that BMAC and PRP combination could lead to better clinical results and better graft maturation/interface healing than PRP alone or conventional ACL reconstruction without any other biologic augmentation.MethodsIn this randomised double-blind prospective study, patients undergoing ACL reconstruction surgery were randomly assigned into three groups: (1) control group (without any biologic augmentation), (2) PRP treatment group, and (3) combined BMAC and PRP (BMAC + PRP) group. Moreover, they were evaluated using the clinical functional score, laxity examination, and magnetic resonance imaging (MRI) analysis.ResultsNo significant difference was observed in the improvement of functional scores among groups. However, laxity improvement at 24 weeks showed a significant difference with the BMAC + PRP group having the lowest laxity. MRI analysis showed no significant change in whole graft maturation among groups. In particular, the BMAC + PRP group showed delayed signal peak and higher graft signal at 24 weeks compared with the other two groups; however, the difference was not significant. With regard to tendon–bone interfacial healing, the BMAC + PRP group showed significantly wider tendon–bone interface in the femoral bone tunnel at 24 weeks compared with the other two groups. Moreover, the BMAC + PRP group showed significantly higher peri-tunnel edema signal in the femoral bone tunnel at 12 weeks compared with the other two groups.ConclusionPRP alone and BMAC and PRP combination showed limited enhancing effect in clinical function, graft maturation and tendon–bone interfacial healing compared with control (no additional treatment). When BMAC is used in ACL reconstruction, the possibility of greater inflammation in the early stage to graft maturation and bone tunnel healing should be considered.

Management of Normogonadotropic males with idiopathic infertility with bilateral varicocelectomy with and without intramuscular recombinant FSH and HCG course(s): A twenty-year- experience in a prospective, controlled, and randomized clinical study

This study presents a clinical prospective double-blinded study that contains three groups of infertile males with normogonadotropic oligoasthenospermia. All groups A, B, and C were operated on for their bilateral varicoceles. The first included 152 patients who were only operated for bilateral varicocele (nominated group A). The second group of 237 patients constituted those who were operated on, with fertile female partners, and whose preoperative spermogram showed a count lower than 15 million/ml and a 3-hour-motility lower than 20%. This group constituted two categories based on their treatment. Therefore, groups B and C received postoperative courses of intramuscular injections of recombinant follicle-stimulating hormone (rFSH) and human chorionic gonadotropin (HCG), i.e., group B received one course (3 months), and group C received two courses (6 months). The main objective is to determine the improvement in the postoperative seminal parameters in the different groups. The sample constituted 391 infertile males who were recruited conveniently based on their willingness to share their progress information and were also informed that they could stop their participation freely with no questions asked. In our treated patients, in both groups B and C, who received 1 or 2 courses of rFSH and HCG, spontaneous pregnancy occurred in 69 patients and 52 patients, respectively. Likewise, assisted pregnancy occurred in 28 and 19 patients, respectively. So treated males of groups B and C resulted in 91/140 (65%) and 61/96 (63.54%) live offspring, respectively.

Impact of oxygen tension during in vitro maturation: a sibling-oocyte prospective double-blinded study

To determine whether oxygen (O2) tension (20% vs. 5%) has an impact on oocyte maturation rates and morphology during invitro maturation (IVM). A prospective, observational, monocentric, sibling-oocyte study. University Hospital. A total of 143 patients who underwent IVM for fertility preservation purposes from November 2016 to April 2021 were analyzed. Patients were included when ≥2 cumulus-oocyte complexes (COCs) were retrieved. The cohort of COCs obtained for each patient was randomly split into two groups: group 20% O2 and group 5% O2. Cumulus-oocyte complexes were incubated for 48 hours either under 5% O2 or 20% O2. After 24 and 48 hours of culture, every oocyte was assessed for maturity and morphology, to estimate oocyte quality. Morphology was evaluated considering six parameters (shape, size, ooplasm, perivitelline space, zona pellucida, and polar body characteristics), giving a total oocyte score ranging from -6 to +6. Maturation rates and total oocyte scores were compared using paired-sample analysis between group 20% O2 and group 5% O2. Patient median age was 31.4 [28.1-35.2] years-old. The mean serum antimüllerian hormone levels and antral follicle count were 3.2 ± 2.3 ng/mL and 27.2 ± 16.0 follicles, respectively. A mean of 10.7 COCs per cycle were retrieved, leading to 6.1 ± 2.4 metaphase II oocytes vitrified (total maturation rate = 57.3%; 991 metaphase II oocytes/1,728 COCs). A total of 864 COCs were included in each group. Oocyte maturation rates were not different between the two groups (group 20% O2: 56.82% vs. group 5% O2: 57.87%, respectively). Regarding oocyte morphology, the mean total oocyte score was significantly higher in group 5% O2 compared with group 20% O2 (3.44 ± 1.26 vs. 3.16 ± 1.32, P=.014). As culture under low O2 tension (5% O2) improves oocyte morphology IVM, our results suggest that culture under hypoxia should be standardized. Additional studies are warranted to assess the impact of O2 tension on oocyte maturation and the benefit of IVM under low O2 tension for embryo culture after utilization of frozen material.

Evaluation of Novel Minimal Screening Antibody Panel for Immunophenotypic Detection of Hematological Malignancies in a Resource-Constrained Setting: A Prospective Study

INTRODUCTION Immunophenotyping of abnormal cells by flow cytometer enabled this technology in diagnosing, prognostication and guiding therapy for blood malignancies. International consensus exist for diagnosis of leukemia, lymphoma and plasma cell neoplasm (PCN) 1-3 using flow cytometer, but it is seldom used for screening these diseases. In clinical setting, including our tertiary care center in India, we come across patients whose peripheral blood (PB) smear examination does not hint towards the type of blood-related disorder. We identified the need to screen these patients by flow cytometry before channelling them towards established diagnostic work-up for malignancies. The aim of this study is to evaluate a flow cytometry screening assay, designed in-house, to detect blood malignancies in a resource-limited (sample, time, cost, infrastructure) clinical setting. MATERIALS AND METHODS This prospective double-blinded study was conducted between November 2022 and June 2023 with institutional ethical approval. Remainder of samples sent for routine clinical tests that met our inclusion/exclusion criteria were selected (n=221). Symptomatic patients with blood-related disorder, whose PB did not show any abnormal cells were included. All patients who had blast, lymphocytosis with atypical lymphocytes, lymphadenopathy, B-symptoms, splenomegaly or found to have plasmacytoma/amyloidosis/CRAB features were excluded. Three tube 8 colour 19 antibody panel (Table1) was designed. Immaturity markers and lineage specific markers are combined in a single tube to detect leukemias. CD5, CD10, CD19, CD20, kappa and lambda were put together to identify B-CLPD. A lyse-wash-stain protocol was followed and the samples were analysed in BD FACSCantoII flowcytometer with autofluroscence and compensation correction done for each sample. The findings of our screening assay were validated with morphological and clinical correlation and GraphPad Prism version 8.0.2 was used for statistical analysis. RESULTS Our antibody panel targeted only cell surface antigens, which reduced the cost of the test and permitted the analysis of the sample within 1 hour. During the study period, out of the 396 discard samples obtained, 221 patients met our inclusion criteria (Figure1). We analysed these samples with our screening assay and detected 51 patients with blood malignancies that included 19 acute leukemias, 11 lymphomas and 21 PCN and 167 samples with no evidence of leukemia, lymphoma or PCN which were subsequently diagnosed with anemias, platelet disorders, drug- or disease-induced leukocytosis/leukopenias and organ dysfunction not involving blood or bone marrow. The number of samples studied and the computed statistical parameters are given in Table2. Representative bivariate dot plots are given in Figure2. Out of the 221 test results, 214 had clinical, morphological and screening test concordance. One case of PCN could not be identified by morphological examination, where screening assay could identify clonal plasma cell population. Another one case was clinically diagnosed as PCN, but missed on screening panel because we did not see a definite cluster of CD38 + cells showing light chain kappa/lambda restriction. The remaining 5 samples were dilute in nature. In 3 out of 5 dilute samples, screening panel could identify the abnormality which was concordant with clinical diagnosis (based on clinical, biochemical, imaging, molecular and cytogenetics) where morphology failed. The other 2 cases were identified morphologically on bone marrow imprint. This flow cytometry screening assay was found to have overall 94.4% sensitivity, 100% specificity, 100% positive predictive value and 98.2% negative predictive value, delineating the efficacy of this minimal antibody screening panel in detecting blood malignancies. CONCLUSION Compared to the existing screening panels, this novel screening test has comprehensive set of antibodies (19 only) to detect leukemia, lymphoma and PCN simultaneously within 1 hour and at a lower cost. In patients screened negative, further blood malignancy-related testing may be avoided, thereby reducing the total cost incurred to the patient. The usefulness of this screening test is limited with dilute sample. However, the present study shows that this screening panel can be used in small resource-constrained and remote settings with a trained flow cytometry technologist alone.

The efficacy of administration of prazosin in reducing the risk of recurrent urethral obstruction in male cats

PICO Question In male cats presenting with urethral obstruction, does administration of prazosin compared with no administration of prazosin reduce the incidence of recurrent urethral obstruction within the first month of initial presentation? Clinical bottom line Category of research Treatment. Number and type of study designs reviewed A total of three studies were included in this appraisal. Two of which were prospective double-blind clinical studies and one retrospective study. Strength of evidence Weak. Outcomes reported Both double-blind studies found no significant difference between prazosin administration and the development of recurrent urethral obstruction (rUO) when compared with a placebo. Both studies, however, did report that cats had a shorter urinary catheterisation time with prazosin administration. The retrospective study found no association between prazosin administration and the risk of rUO and found that after 14 days post discharge, significantly more 73/302 (24%) cats that received prazosin had experienced rUO compared to 11/86 (13%) of cats that did not. One study found side effects to the administration of prazosin which may be detrimental to the overall recovery. Conclusion Administration of prazosin does not reduce the risk of rUO within 30 days of presentation. However, the strength of evidence is weak and would benefit from further clinical studies. How to apply this evidence in practice The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources. Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.

Effect of Preoperative Oral Carbohydrate Loading on Perioperative Hemodynamic in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Study

Background: Conventional preoperative fasting is associated with intravascular volume contraction, increased stress, hyperglycaemia in the perioperative period. Recently, the concept of preoperative carbohydrate loading is introduced. This study was conducted to reveal the relation between use of carbohydrate-rich fluid and perioperative hemodynamic, perfusion index, and glucose control of the patients, who were undergoing elective laparoscopic cholecystectomy under general anesthesia. Methods: This study is a double-blinded prospective randomized control study. The patients, who met the inclusion criteria were randomly divided into 2 groups of 43 each with the help of computer-generated randomization method. Patients who received preoperative carbohydrate loading and patients who follow conventional preoperative fasting for surgery were labelled as Group E and Group S respectively. Incidence of hypotension was the primary outcome; variation in blood pressure, heart rate, perfusion index, and blood glucose level were the secondary outcomes. Results: Intraoperative hypotensive episodes were significantly lower in the carbohydrate loading group in comparison to the conventional fasting group, p=0.023. The systolic, diastolic blood pressure and perfusion index were significantly lower in the conventional fasting group. Also, the heart rate was significantly higher in the conventional fasting group. Numeric rating scale, the score for pain taken at 1 hour postoperatively was significantly lower in the carbohydrate loading group. Blood glucose level postoperatively after 24 hours was significantly more in the conventional fasting group. Conclusion: The carbohydrate loading group has better hemodynamic stability and optimal intravascular volume after induction and intraoperatively. Also, the carbohydrate loading group had better glycaemic control and better pain relief postoperatively.