Prospective Double-blind Study Research Articles

Beneficial clinical effects of honey from bees fed with specific plant extracts

Abstract Background Our team has demonstrated in a number of pre-clinical studies that special bees fed with syrups containing natural plant extracts contain a number of active substances that have beneficial effects on the human body. We have previously reported that bees fed with green walnut have beneficial effects on sugar metabolism, lowering serum glucose levels and reducing insulin resistance. Methods We conducted a prospective double-blind functional food study with 45 healthy volunteers using a strict inclusion and exclusion criteria with ethical approval. Participants ate 30 gramms of honey layered under 150 ml of yoghurt twice a day for 3 weeks. Fifteen participants consumed honey from bees fed with green walnut extract, while 15 participants consumed honey from bees fed with sea buckthorn extract, and 15 participants in the control group consumed acacia honey. Sleep quality was assessed with the SQS questionnaire, and quality of life with the SF-36, EORTC Q-C30 and EQ-5D tests on days 0 and 22 of the study. Results Consumption of both specific honey resulted improvements in the life quality parameters and in the sleep quality. ‘Buckthorn honey’ showed significant differences after the 3rd week: physical function improved (25.3±0.5 vs 27.4±2.8; p = 0.04), anxiety-depression decreased (1.4±3.6 vs 1±0.3; p = 0.03), complex physical status (84.1±9.7 vs 88.7±6.9; p = 0. 04), while ‘green walnut honey’ improved EQ-5D complex quality of life (84.1±9.7 vs 88.9±6.9; p = 0.01), overall quality of life functioning (90.6±14.9 vs 99.2±4.2; p = 0.03), EORTC Q-C30 total score (467.1±30.6 vs 487.4±21.4; p = 0.03).No such positive effects were confirmed in the control group. Conclusions Honey from bees fed with sea buckthorn extract has many beneficial physiological effects on the human body, improving physical well-being and reducing anxiety and depression. Honey from bees fed with green walnut extract improves the complex quality of life. Key messages • Improving the quality of life with nutrition is an increasingly important research field, playing a key role in our life. • Our research has shown that honey from bees fed with green walnut and sea buckthorn extract improves several parameters in the quality of life.

Beneficial effect of honey from algae extract-fed bees on quality of life

Abstract Background Our team has been researching and developing special honeys from bees fed with syrups containing natural plant extracts for decades. Several pre-clinical studies have demonstrated that honey from bees fed with Chlorella algae extract contains a number of algal active ingredients with beneficial effects on the human body. Methods We conducted a prospective double-blind functional food study with 30 healthy volunteers with ethical approval. Based on strict inclusion and exclusion criteria, 30 gramms of honey has been eaten twice a day for 3 weeks under 150 ml of yoghurt. 15 people were fed honey from bees with special algae extract, while 15 concerned - as a control group - consumed acacia honey. Before and after the study, sleep quality was assessed by the SQS questionnaire, and quality of life by the SF-36, EORTC Q-C30 and EQ-5D tests. Results The specific algae extract contained honey improved the people’s sleep quality, their EQRTC parameters, their appetite, their digestion, and it also significantly reduced pain (p = 0.01), boosted the patients cognitive function, and reduced both constipation and diarrhoea. Significant differences in SF-36 parameters: pain decreased (12.9±1.6vs 6.6±1.1; p = 0.01), physical function (21.2±6.3vs 27.1±3.6; p = 0.01) and energy (11.2±2.7vs 13.9±1.4; p = 0.01) improved. No such changes occurred in control group. Conclusions Honey from bees fed with algae extract has a number of beneficial physiological effects on the human body, improving many parameters of quality of life. Key messages • The consumption of honey from bees fed with algae extract improves sleep, reduces pain, and has a positive effect on digestive and gastrointestinal symptoms. • Within public health, quality of life is an increasingly important issue and improving it with functional foods is an important area of research.

Evaluation of gabapentin administration on neurologic examination in 2 different age groups of healthy cats.

Gabapentin is often administered PO for preappointment or in-hospital anxiolysis in cats. A previous study reported mild changes on the neurologic examination after administration. Investigate the effects of gabapentin on anxiety, sedation, compliance, and neurologic examination in 2 age groups of cats. Thirty-one young cats and 12 geriatric cats perceived by their owners to be healthy and neurologically normal. Prospective double-blinded clinical crossover study. Assessment of baseline sedation and anxiety was performed before initial neurologic examinations and after gabapentin administration (100 mg/cat). Assessments were repeated 90 to 120 minutes after administration. Ease of handling pregabapentin and postgabapentin was assessed in the younger cats. All examinations were performed by a board-certified veterinary neurologist and scoring of examinations was performed by a different, masked board-certified neurologist. Sixteen cats (50%) in the younger cohort and 6 cats (50%) in the geriatric cohort exhibited an increase in their overall neurologic examination score postgabapentin administration, mainly through new or progressive postural reaction deficits and gait changes. Anxiety and sedation scores were significantly changed in the geriatric population (P < .01, P = .004, respectively); however, only sedation scores were significantly increased in the younger cats after gabapentin administration (P = .004). All study participants showed mild neurologic changes after gabapentin administration, most markedly noted in the geriatric population. Dose reduction of gabapentin for preappointment anxiolysis and neurologic examination in geriatric patients should be considered.

Neuromuscular ultrasound for the differential diagnosis of radial tunnel syndrome and lateral epicondylitis.

Lateral elbow pain is quite common in everyday life. Lateral epicondylitis and radial tunnel syndrome are the most common causes of lateral elbow pain. The aim of this study was to evaluate the sensitivity and specificity of neuromuscular ultrasound examination in the diagnosis of lateral epicondylitis versus radial tunnel syndrome. This was a prospective double-blinded pilot study of 68 elbows in 34 patients with lateral elbow pain. Patients underwent clinical examination and standardized neuromuscular ultrasound evaluation in the first 15days after the initiation of symptoms. Statistical significance was set at p<.001. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Sixty-eight radial nerves were examined in 34 healthy controls (16 males; mean age 48.1±8.2years). Pain with palpation over the radial tunnel was found in 25 of 48 elbows (52.1%) compared to the pain over the lateral epicondyle found in 10 of 48 elbows (20.8%). Τhe sensitivity of palpation in differentiating radial tunnel syndrome from lateral epicondylitis was 75.7%, while the specificity was 50% (PPV 71.4%, NPV 51.5%). The sensitivity of neuromuscular ultrasound in differentiating radial tunnel syndrome from lateral epicondylitis was 92.6%, while the specificity was 80% (PPV 92.6%, NPV 80.0%). In most of the patients (25/31), fibrous bands anterior to the radio-capitellar joint were responsible for the nerve entrapment. The present study highlights the importance of the neuromuscular ultrasound's diagnostic role in differentiating radial tunnel syndrome from lateral epicondylitis in the clinical scenario of lateral elbow pain.

Liposomal Bupivacaine Does Not Decrease Postoperative Pain in Patients with Intracapsular Femoral Neck Fracture Treated with Hemiarthroplasty: HEAT-A Randomized, Controlled Trial.

Liposomal bupivacaine (LB) is a long-lasting local anesthetic agent that was developed for use in the surgical setting to help manage postoperative pain. The objective of this study was to evaluate the effect of LB on postoperative pain, function, and overall hospital course in patients with intracapsular hip fractures who were treated with hip hemiarthroplasty. This was a single-center, randomized prospective double-blinded study of 50 patients with an isolated intracapsular femoral neck fracture who were treated with hip hemiarthroplasty from 2018 to 2022. The study group consisted of 25 patients who were treated with intraoperative LB and bupivacaine hydrochloride injections, while the control group consisted of 25 patients who were treated with intraoperative bupivacaine hydrochloride injections only. Primary outcomes were a visual analog scale (VAS) score for pain, total morphine milligram equivalents (MME), delirium, and time to ambulation with physical therapy. No significant differences between the study and control groups were found in any of the outcomes measured. Most notably, there were no differences in the average postoperative pain score (VAS, 2.26 versus 2.7; p = 0.34), total MME used postoperatively (11.73 versus 9.98 MME; p = 0.71), and postoperative day of discharge (4.00 versus 3.88 days; p = 0.82). The results of our study suggest that use of LB is not associated with substantially improved postoperative pain or function or with a shorter hospital course following hip hemiarthroplasty for a femoral neck fracture. Given the higher cost of LB compared with standard postoperative pain modalities, it is worth questioning its use in the setting of geriatric hip fractures. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Intranasal administration of insulin on the incidence of postoperative delirium in middle-aged patients undergoing elective on-pump cardiac surgery (INIPOD-MOPS): a prospective double-blinded randomized control study protocol

BackgroundDelirium, marked by acute cognitive decline, poses a life-threatening issue among older individuals, especially after cardiac surgery, with prevalence ranging from 15 to 80%. Postoperative delirium is linked to increased morbidity and mortality. Although clinical trials suggest preventability, there is limited research on intranasal insulin (INI) for cardiac surgery-related delirium. INI has shown promise in managing cognitive disorders. It rapidly elevates brain hormone levels, enhancing memory even in non-impaired individuals. While effective in preventing delirium in gastrointestinal surgery, its impact after cardiac surgery remains understudied, especially for middle-aged patients.MethodThis is a prospective randomized, double-blind, single-center controlled trial. A total of 76 eligible participants scheduled for elective on-pump cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either receive Intranasally administered insulin (INI) or intranasally administered normal saline. The primary outcome of our study is the incidence of postoperative delirium (POD). Secondary outcomes include duration of ICU, postoperative hospital length of stay, all in-hospital mortality, the change in MMSE scores pre- and post-operation, and incidence of postoperative cognitive dysfunction at 1 month, 3 months, and 6 months after operation. Moreover, we will subjectively and objectively evaluate perioperative sleep quality to investigate the potential impact of nasal insulin on the development of delirium by influencing sleep regulation.DiscussionOur study will aim to assess the impact of intranasal administration of insulin on the incidence of postoperative delirium in middle-aged patients undergoing on-pump elective cardiac surgery. If intranasal insulin proves to be more effective, it may be considered as a viable alternative for preventing postoperative delirium.Trial registrationChiCTR ChiCTR2400081444. Registered on March 1, 2024.

TO ASSESS THE ROLE OF NASAL TAPENTADOL AS PRE-EMPTIVE ANALGESIA, IN BREAST SURGERY PATIENTS

Patients undergoes moderate to severe postoperative pain after surgery, which is troublesome during the postoperative period. Inadequately treated acute post operative pain causes prolonged morbidity to patients. Pre-emptive analgesic minimises the pain in perioperative period by central neuro sensitization. We assessed the role of Nasal Tapentadol in breast surgery patients, as a pre-emptive analgesic, in the reduction of post-operative analgesic requirement. In a double blinded prospective randomized control study, sixty breast surgery patients, received nasal spray of tapentadol (Group A) or saline Spray (Group B), 30 minutes prior to general anaesthesia. Perioperative analgesic requirement, time taken for first analgesic requirement in post operative period, post operative pain and sedation scores, we compared the following parameters in the first 24h during the postoperative period in all patients: Analgesic requirement during perioperative period, time taken for first post operative analgesic dose, pain score and sedation score in postoperative period.Data Of all sixty patients were analysed. Patients in Tapentadol Group A had significantly lower requirement of analgesics and lower Visual analog scale (VAS) than Saline group in the post operative period. However, Ramsay sedation score was more in Tapentadol group, immediately after shifting the patient to the postanaesthetic care unit. Single Pre-emptive nasal spray of tapentadol (45mg) is an effective intervention to, reduce the surgical pain and lesser requirement of analgesics, in post operative period, without added side effects.

Effects of supplementing extracorporeal shockwave therapy (ESWT) to hyaluronic acid (HA) injection among patients with rotator cuff lesions without complete tear: A prospective double-blinded randomized study.

The study investigates the combined efficacy of subacromial hyaluronic acid (HA) injections and extracorporeal shockwave therapy (ESWT) in managing rotator cuff lesions without complete tears. Eligible patients were randomized into three groups: 3 HA injections combined with 2 sham ESWT (HA), 3 HA injections combined with 1 ESWT and 1 sham ESWT (HA + 1 ESWT), or 3 HA injections combined with 2 ESWT (HA + 2 ESWT) with an allocation ratio of 1:1:1. Visual Analogue Scale (VAS), Constant-Murley Score (CMS), range of motion (ROM), and muscle power of shoulder abduction (MP) were assessed pre-intervention and at 1, 3, 6, and 12 months post-initial HA injection. Shoulder magnetic resonance imaging (MRI) was conducted before and twelve months after the intervention. All pertinent parameters showed no significant between-group differences at baseline but demonstrated significant within-group improvement throughout the study. The HA + 1 ESWT group demonstrated superior improvements in MP (P=0.011) and CMS (P=0.018) at 1 month, and in MP (P=0.014) and CMS (P=0.005) at 6 months, compared to the HA group. The HA + 2 ESWT group showed greater improvements in FF (P=0.027), IR (P=0.019), and SROM (P=0.025) at 1 month, and in ABD (P=0.022) at 6 months, compared to the HA group. Notably, the HA + 2 ESWT group exhibited greater improvements in FF (P=0.013), IR (P=0.019), and SROM (P=0.025) at 1 month, and in FF (P=0.007) at 3 months, than the HA + 1 ESWT group. Moreover, no deterioration in tendinopathy grading or tear status occurred in the HA + 1 ESWT group on MRI scans. ESWT provides additional benefits when combined with HA injections for patients with rotator cuff lesions lacking complete tears.

An observational study to compare the efficacy of intravenous dexmedetomidine versus intravenous esmolol for attenuation of pressor response during laryngoscopy and endotracheal intubation

Laryngoscopy and endotracheal intubation during general anaesthesia is an invasive stimulus associated with release of circulating catecholamine leading to hemodynamic and cardiovascular responses resulting in tachycardia, hypertension and arrhythmias. Many prophylactic drugs have been used to decrease cardiovascular response to laryngoscopy &amp; intubation. Aim of this study is to compare effectiveness of Dexmedetomidine 1μg/kg and Esmolol 1 mg/kg intravenously in attenuating cardiovascular response during laryngoscopy and intubation during general anaesthesia.This randomised double blinded prospective study was conducted on 50 patients, of either gender between age group 18-60 years and American Society of Anaesthesiology (ASA) classification I &amp; II, undergoing various surgeries under General anaesthesia requiring intubation. Patients were randomly divided into 2 groups of 25 patients each. Group D patients received intravenously Inj. Dexmedetomidine 1 mcg/kg as an infusion in 100ml Normal Saline over 20 minutes before induction of general anaesthesia. Group E patients received intravenously Inj. Esmolol 1 mg/kg diluted with normal saline to volume of 10ml given just before induction of general anaesthesia.Hemodynamic parameters such as Heart rate (HR),systolic blood pressure (SBP),diastolic blood pressure (DBP) and mean arterial pressure (MAP) were recorded at baseline, after study drug administration, after induction, at laryngoscopy and intubation and 1, 3, 5 and 7 min after Endotracheal intubation.: Comparison of two groups reveals that dexmedetomidine shows less rise in heart rate (P-0.0003) and mean arterial pressure (P-0.0106) at the laryngoscopy and intubation. It also shows less rise in systolic and diastolic blood pressure after induction and after intubation (P&amp;#60; 0.05) than Esmolol. This study suggests that Dexmedetomidine 1µg/kg was more effective in attenuating the stress response to laryngoscopy and intubation as compared to Esmolol 1mg/kg.

Comparison of the perceived image quality of intraoral orthodontic photographs taken with DSLR camera and mobile phone camera: A double-blinded prospective study

Clinical orthodontic photography is a vital skill that every orthodontist should master to record the patients’ details and to permit the orthodontist to carefully plan, monitor and execute the treatment. With the advancement of technology, some clinicians opt to take intraoral photographs with their mobile phone rather than DSLR camera. Hence, this study aimed to answer one main question: whether there was any significant difference in the perceived quality image between intraoral photos taken with a mobile phone and a standard DSLR camera. The cameras used were a DSLR (Nikon D300s with AF-S Micro NIKKOR 105mm lens and NIKON R1C1 Twin Flash) and Mobile Phone (Apple I-Phone 11 with Selfie Ring Light). Assessment of 20 sets of intraoral photographs (100 individual images) by five IIUM orthodontists using a perceived quality Likert scale of Zero (0) to Ten (10). The assessors and the lead investigator were blinded to the source of the photographs. Reliability was evaluated using a test-retest method on 4 sets of intraoral photographs (20 individual images), a few weeks after their initial assessment. There was no significant difference (p=0.35) in perceived quality of intraoral photographs taken between DSLR and mobile phone, with the mean value of 7.34 and 7.12 respectively. Reliability was good (ICC=0.549). This prospective study showed that there was no statistical difference between the perceived quality of intraoral orthodontic photographs taken with a DSLR camera and a Mobile Phone camera.

Ultrasound Guided Bilateral Erector Spinae Plane Block vs Intravenous Patient-Controlled Analgesia for Pain after Total Laparoscopic Hysterectomy

Abstract Background Pain is an everyday challenge during all surgeries and it is a chief postoperative complication, so pain management is a corner stone in anesthetic practice. Total Laparoscopic Hysterectomy (TLH) is a minimally invasive procedure, it has certain advantages over an open abdominal hysterectomy, such as reduced pain, less incidences of wound infection, a rapid recovery, a shorter hospital stay and lower complication Aim of the Work The present study was designed to assess the analgesic efficacy and safety of ultrasound guided ESPB done at lower thoracic transverse process level in patients undergoing TLH for postoperative analgesia versus intravenous patient-controlled analgesia. Patients and Methods This study is as Prospective double blinded cohort study, it was performed on Patients undergoing elective Total laparoscopic hysterectomy (TLH) in the hospital of gynecology of Ain Shams university hospitals over a period of six months. Patients who fulfilled the inclusion criteria and agreed to participate in the study were randomly divided into two groups using computer-generated randomized list such that group A for ESPB and group B for PCA. Results The main finding in this study was that ultrasound guided ESPB at level of thoracic process provided a good analgesic effect in patients undergoing TLH also reduced the need for rescue analgesia and the total amount of postoperative opioid consumption in comparison to PCA group, Prolonged the time to first request of analgesia (duration of analgesia), Provided early mobilization, Increase patient satisfaction in 1st 24 hour and Decrease incidence of nausea and vomiting due to decrease opioids intake. Conclusion Ultrasound-guided erector spinae plane block was found statistically efficient in reducing postoperative opioid consumption, alleviating postoperative pain scores and improving patients’ satisfaction in the first 24 hours after TLH, without associated adverse effects or complications like nausea and vomiting, nerve injury, respiratory depression and hematoma formation.

Blood stored in EDTA tubes provides accurate peanut basophil activation test results for 48 hours

BackgroundThe peanut basophil activation test (BAT) has demonstrated excellent diagnostic accuracy with heparinized blood, but its clinical utility is limited by the short stability of samples stored in this anticoagulant. ObjectiveUsing EDTA anticoagulated blood, these investigations determined if Peanut BAT sample stability can be extended to 2 days, the minimum stability requirement for diagnostic tests currently offered through American reference laboratories. MethodsPeanut non-allergic control (NAC), peanut IgE sensitized (PS), and peanut allergic (PA) children aged 6 months through 17 years were recruited from members of Kaiser Permanente Southern California. EDTA anti-coagulated blood samples were collected from participants, shipped to a centralized laboratory, and stored at 4oC for peanut BAT testing 1 and 2 days later. ResultsPeanut BAT results for 23 unblinded participants were used to establish sample rejection and interpretation criteria that were subsequently validated in a prospective double-blind study involving 112 additional children (39-NAC, 36-PS, 37-PA). Of 105 blinded blood samples tested on each study day, 88 (84%) day-1 and 90 (86%) day-2 peanut BAT results were considered interpretable, with diagnostic accuracies of 95.5% and 94.4%, respectively. Moreover, all interpretable PA results were considered positive (100% sensitivity). ConclusionUsing EDTA anti-coagulated blood samples collected remotely, 1 and 2 days before testing, study results highlight the favorable diagnostic performance characteristics of the peanut BAT and provide further evidence that the test could be readily operationalized for clinical use by interested commercial reference laboratories.

Preoperative nebulization with dexamethasone or magnesium sulfate for prevention of incidence and severity of postoperative sore throat – A prospective randomized comparative study

Introduction: Postoperative sore throat (POST) is a common cause of distress and dissatisfaction after general anesthesia. POST is one of the most distressing symptoms after general anesthesia. Incidence of POST ranges from 14.4% to 90% following laryngoscopy and tracheal intubation. Various drugs with different routes are examined to prevent POST. We intended to compare the effectiveness of nebulized dexamethasone and magnesium sulfate (MgSO4) in decreasing the incidence and severity of POST. Materials and Methods: In this prospective double-blind study, adult patients with either sex undergoing laryngoscopy and intubation for surgery were randomly assigned into dexamethasone (Group D) and MgSO4 (Group M). The primary outcome was to assess incidence and severity of POST, and secondary outcome was to assess the incidence of hoarseness and cough. Continuous variables were presented as mean ± standard deviation, and t-test was applied for comparing the difference of means between the two groups. P ≤0.05 was considered statistically significant. Results: The incidence of POST in Group D was much lower as compared to Group M at 0 h (P = 0.0262), but after that, there was no significant difference between groups. Severity of POST was compared between Group D and Group M at 0, 4, 8, 12, and 24 h postoperatively. At 0 h, Group D had 22 patients with no pain at rest (Grade 0) whereas Group M had 12 patients. The secondary outcomes (pain at deglutition, hoarseness, and cough) at 0, 4, 8, 12, and 24 h were not statistically significant (P &gt; 0.05). Conclusions: Preoperative MgSO4 nebulization is as effective as dexamethasone nebulization in decreasing the incidence and severity of POST without causing any adverse effect. Incidence of pain on deglutition, hoarseness, and cough are also reduced effectively by both drugs.

A prospective double-blind clinical study: Effect of probiotics and thalidomide on radiation enteritis in patients with pelvic cancer undergoing concurrent chemoradiotherapy.

e23013 Background: Radiation induced diarrhea (RID) is one of the commonest and most distressing side effects during and after radiotherapy predominantly in patients whose irradiation region is pelvis. Thalidomide reduces severity as well as the frequency indicated in RID but mechanism of action is not elucidated. Probiotics are beneficial microorganisms that may regulate flora of intestines to increase immunity and have a protective effect on RID. This pilot study was designed to ascertain effects of thalidomide and probiotics on RID in patients being subjected to pelvic irradiation. Methods: A double-blind, single-center, randomized pilot study was conducted. Patients were classified into two groups as thalidomide plus probiotics (Lactobacillus rhamnosus + Probio-M9, ) group (TP group) or plus placebo group (P group).Incidence of grade 3/4 diarrhea, was a primary endpoint of the study. Other secondary endpoints analyzed were rates and severity of diarrhea, antibiotics use, body weight, albumin, and lymphocyte changes. 31 patients undergoing pelvic radiotherapy with or without concurrent chemotherapy were randomly selected from government tertiary general hospital. Results: The incidence of grade 3/4 diarrhea was 9.5% (95% CI: 0 to 24.5%) in TP, which was significantly different from historical data of 30% to 60%. The incidence of grade 3/4 diarrhea in group P was 19.8% (95% CI: 0~41.3%). The frequency and severity of diarrhea in group TP were little less than in group P. There is no significant difference between them. Basically, the time for antibiotic use in groups P and TP was the same, with a slightly longer time from first antibiotic exposure in group TP as compared to group P. The moment of first antibiotics have been prescribed in our study patients, this was better than that of a clinical routine treatment experience and other research data according to the literature. The changes in body weight, albumin level, and lymphocyte at different stages before and after radiotherapy in group TP were not statistically significant, and the level of body weight and albumin in group P was slightly reduced compared with before radiotherapy but increased compared with group TP after radiotherapy. Furthermore, there were no severe adverse effects regarding thalidomide as well as probiotics reported among patients who participated in this study. Conclusions: The combined treatment with thalidomide and probiotics is beneficial to ameliorate RID in patients receiving pelvic radiotherapy, yet this study can't represent whole conclusion due to small size of patients. We will also need larger, multicenter double-blind placebo-controlled trials to confirm exact efficacy and safety of this combined treatment. Clinical trial information: NCT05059613 .

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.

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.