Double-blind Controlled Study Research Articles

Letter to the Editor: Lumbar transforaminal injection of steroids versus platelet-rich plasma for prolapse lumbar intervertebral disc with radiculopathy: a randomized double-blind controlled pilot study.

Letter to the Editor: Lumbar transforaminal injection of steroids versus platelet-rich plasma for prolapse lumbar intervertebral disc with radiculopathy: a randomized double-blind controlled pilot study.

The role of frontal cortex in novel-word learning and consolidation: Evidence from focal transcranial direct current stimulation

Previous studies have demonstrated that conventional transcranial direct current stimulation (tDCS) can enhance novel-word learning. However, because of the widespread current that is induced by these setups and lack of appropriate control conditions, little is known about the underlying neural mechanisms. In the present double-blinded and sham-tDCS controlled study, we investigated for the first time if regionally precise focal tDCS targeting two key nodes of the novel-word learning network at different time points would result in regionally and temporally distinct effects. 156 participants completed a contextual novel-word-learning paradigm and learning success was probed immediately after the acquisition period and 30-min later. Participants were randomly assigned to six stimulation conditions: Active tDCS (1.5 mA) was administered to left inferior frontal (IFG) or middle temporal gyrus (MTG), either during acquisition or delayed recall. Control groups received sham-tDCS either during acquisition or delayed recall (50% IFG/MTG). Data were analyzed with a generalized linear mixed model with a binomial link function in a Bayesian framework. Our results showed that frontal tDCS selectively increased accuracy gains from immediate to delayed recall, irrespective of timing of the stimulation. There was no evidence for beneficial effects of middle temporal gyrus tDCS. Our findings confirm that IFG tDCS can enhance novel-word learning in a regionally, but not timing specific way. Tentatively, this may be explained by enhancement of semantic selection processes resulting in more effective consolidation and/or retrieval. Future studies using longer time intervals between assessments are required to clarify the potential contribution of neurophysiological after-effects of IFG tDCS administered during acquisition to enhanced consolidation.

Effects of probiotic supplementation on 12 min run performance, mood management, body composition and gut microbiota in amateur marathon runners: A double-blind controlled trial

BackgroundProbiotic supplementation has a positive effect on endurance exercise performance and body composition in athletes, but the underlying mechanisms remain unclear. Gut microbiota can provide measurable markers of immune function in athletes, and microbial composition analysis may be sensitive enough to detect stress and metabolic disorders caused by exercise. MethodsNineteen healthy active amateur marathon runners (15 male and 4 female) with a mean age of 29.11 years volunteered to participate in this double-blind controlled study. Based on the performance of the Cooper 12-min running test (CRT), the participants were allocated into two groups to receive either a probiotic formulation comprising lactobacillus acidophilus and bifidobacterium longum (n = 10) or placebo containing maltodextrin (n = 9) for five weeks. Consistency of diet and exercise was ensured throughout the experimental period. Before and after the intervention, all participants were assessed for CRT, emotional stability and gastrointestinal symptoms, gut microbiota composition, body composition and magnetic resonance imaging (MRI) indicators of skeletal muscle microcirculation. ResultsCompared to before the intervention, the probiotics group showed an increase in CRT score (2.88 ± 0.57 vs 3.01 ± 0.60 km, P＜0.05), significant improvement in GSRS and GIQLI (9.20 ± 4.64 vs 7.40 ± 3.24, 118.90 ± 12.30 vs 127.50 ± 9.85, P＜0.05), while these indicators remained unchanged in the control group, with a significant time-group interaction effect on gastrointestinal symptoms. Additionally, some MRI metabolic cycling indicators of the thigh skeletal muscle also changed in the probiotics group (P＜0.05). Regarding microbiota abundance, the probiotics group exhibited a significant increase in the abundance of beneficial bacteria and a significant decrease in the abundance of harmful bacteria post-intervention (P＜0.05). ConclusionAs a sports nutritional supplement, probiotics have the potential to improve athletic performance by optimizing the balance of gut microbiota, alleviating gastrointestinal symptoms.

Comparison of the dural puncture epidural and the standard epidural techniques in patients having labor analgesia maintained using programmed epidural boluses: a prospective double-blinded randomized clinical trial

BackgroundThe dural puncture epidural technique has been shown in some studies to improve the onset and quality of the initiation of labor analgesia compared with the standard epidural technique. However,...

Comparison of the effect of intraoperative dexmedetomidine versus ketamine on postoperative analgesia in fracture femur patients operated under subarachnoid block – A prospective randomized double-blind controlled trial

Abstract Background and Aims: Intravenous sedation during spinal anesthesia has the advantages of increased duration of spinal anesthesia and better postoperative pain control. The aim of this study was to compare the effect of intravenous bolus and infusion of dexmedetomidine versus ketamine given intraoperative on the postoperative analgesia in fracture femur patients operated under subarachnoid block. Material and Methods: In this prospective randomized double-blind controlled study, 75 patients aged 18–65 years posted for elective surgery were selected and randomly divided into three groups to receive ketamine (group K), dexmedetomidine (group D), and saline (control group C). Postoperative pain was evaluated using the numerical rating scale (NRS). The duration of analgesia and the amount of analgesic consumption were also recorded. Student’s t-test and Chi-square test were used to compare the two groups, and one-way ANOVA with posthoc analysis was performed for comparison of the three groups. Results: Patients in the ketamine group had better postoperative analgesia as assessed by decreased pain (on the NRS scale) and decreased need for postoperative rescue analgesics (P < 0.001). The duration of sensory block and motor block was prolonged in group K as compared to the other two groups (P < 0.001). Conclusion: Intraoperative use of intravenous ketamine was superior to dexmedetomidine for postoperative analgesia in fracture femur patients operated under subarachnoid block.

Effect of Dexmedetomidine Premedication on Sevoflurane Requirement using BIS during General Anaesthesia in Laparoscopic Cholecystectomy

Background: Dexmedetomidine is a highly selective α2-adrenoreceptor agonist with sedative, anxiolytic and analgesic properties without any respiratory depression. It decreases the requirement of volatile anaesthetics with better hemodynamic stability in surgical patients. We avoided the risk of awareness under anaesthesia by using Bispectral index. Aims: To evaluate the efficacy of Dexmedetomidine pre-medication on Sevoflurane requirement and to assess the haemodynamic stability during elective laparoscopic cholecystectomy surgeries. Methods: Randomized double-blind control study. Design: Forty eight patients were randomly allocated into two groups. Group A received saline infusion and Group 2 received Dexmedetomidine infusion in a dose of 1µg/kg over 15 min before induction. Vital parameters and bispectral index were noted throughout the surgery. Patients were induced and intubated as per the standard protocol and maintained with Oxygen & Nitrous oxide (1 litre Oxygen + 2 litre Nitrous oxide) with Sevoflurane concentration adjusted to achieve BIS values of 45–55. Demographic profile, hemodynamic parameters total Sevoflurane consumption were noted. Statistical Analysis: Statistical analysis was performed using SPSS software version 22.0. Percentage analysis was done for qualitative data. Parametric data were compared using an unpaired t-test. Nonparametric data were compared with Fisher’s exact test or Chi-square test. Results: Mean Sevoflurane consumption in Group A and Group B were 0.379 ± 0.10, 0.169 ± 0.05 ml/min respectively with P<0.001 which was statistically significant. A 55.4% reduction in Sevoflurane consumption was found in patients receiving Dexmedetomidine premedication. Conclusions: Dexmedetomidine premedication is useful to reducing Sevoflurane consumption during general anesthesia and it provides better haemodynamic stability.

Effects of Different Volumes of Ropivacaine for Pericapsular Nerve Group Block on Incidence of Quadriceps Weakness and Analgesic Efficacy Following Hip Arthroplasty: A Randomized Controlled Trial.

The pericapsular nerve group (PENG) block has been shown to be an effective approach to alleviating pain and reducing the need for opioids among older adults following hip surgery, with possible motor-sparing effects. No reports to date, however, have described appropriate ropivacaine volumes for use in the context of PENG block. The present prospective randomized controlled study was thus developed to assess the quadriceps muscle strength and analgesic efficacy associated with PENG block performed using three different volumes of 0.33% ropivacaine following general anesthesia in older adults undergoing hip arthroplasty. In this prospective randomized double-blind controlled clinical study, 60 patients were assigned at random to undergo ultrasound-guided PENG block for hip arthroplasty using different volumes of ropivacaine. Specifically, these patients were administered 10ml (Group A, n = 20), 20ml (Group B, n = 20), or 30ml (Group C, n = 20) of 0.33% ropivacaine. Quadriceps muscle strength was evaluated at 6h post-surgery. Visual analog scale (VAS) scores at rest and with movement were assessed at 4, 6, 12, and 24h post-surgery. Block duration, adverse event incidence, and patient satisfaction were evaluated at 24h post-surgery. Quadriceps motor block incidence rates at 6h post-surgery in the 10ml, 20ml, and 30ml groups were 5%, 20%, and 75%, respectively. Quadriceps muscle weakness at 6h post-surgery was significantly more common in the 30ml group relative to the others (p < 0.001). Patients administered 10ml 0.33% ropivacaine exhibited significantly higher VAS pain scores at rest and with movement relative to those patients in the 20ml and 30ml treatment groups at all time points (p < 0.05). No apparent differences in analgesic efficacy were observed when comparing the 20ml and 30ml groups at 4, 6, 12, and 24h post-surgery. No significant differences in block duration, satisfaction, or adverse event incidence were observed among groups. The preservation of motor function in the 20ml 0.33% ropivacaine group was superior to that in the 30ml 0.33% ropivacaine group. Relative to the group that received 10ml 0.33% ropivacaine during PENG block, those elderly patients administered 20ml and 30ml volumes of 0.33% ropivacaine experienced superior postoperative pain relief following hip arthroplasty.

The differential effect of modern intravenous iron on fibroblast growth factor 23 and phosphate in non-dialysis dependent CKD – the exploratory randomized controlled double-blind ExplorIRON-CKD study

BackgroundIntravenous iron is commonly used in patients with non-dialysis-dependent chronic kidney disease (CKD). Modern intravenous iron compounds (e.g. ferric derisomaltose (FDI), ferric carboxymaltose (FCM)) are increasingly utilized with similar efficacy. A differential effect in terms of hypophosphatemia has been noted following administration of FCM, which may be related to fibroblast growth factor 23 (FGF23). This study was designed to examine the comparative effects of FDI and FCM on FGF23, phosphate and other markers of bone turnover.MethodsThe single-center double-blind randomized controlled trial “Iron and Phosphaturia – ExplorIRON-CKD” primarily assessed the effects of FCM and FDI on intact FGF23 and phosphate, whilst also studying the impact on vitamin D, parathyroid hormone and phosphaturia. Bone markers including alkaline phosphatase, bone-specific alkaline phosphatase, procollagen type 1 N-terminal propeptide and carboxy-terminal collagen cross-linked telopeptide were monitored. Non-dialysis-dependent CKD patients (stage 3a-5) with iron deficiency with/without anemia (serum ferritin < 200 µg/L or transferrin saturation = 20% and serum ferritin 200-299 µg/L) were randomized to receive FDI or FCM in a 1:1 ratio. At baseline 1000 mg of intravenous iron was administered followed by 500-1000 mg at 1 month to achieve replenishment. Measurements were performed at baseline, 1–2 days following iron administration, 2 weeks, 1 month (second iron administration), 1–2 days following second administration, 2 months and 3 months following initial infusion.ResultsTwenty-six patients participated in the trial; 14 randomized to FDI and 12 to FCM. Intact FGF23 increased following administration of iron, and the increase was significantly higher with FCM compared to FDI (Baseline to 1–2 days following 1st administration: FDI: 3.0 (IQR: - 15.1 - 13.8) % vs. FCM: 146.1 (IQR: 108.1–203.1) %; p < 0.001 and Baseline to 1–2 days following 2nd administration: FDI: 3.2 (IQR: - 3.5 – 25.4) % vs. FCM: 235.1 (138.5–434.6) %; p = 0.001). Phosphate levels decreased in the FCM group, causing a significant difference versus FDI 2 weeks following administration of the first dose. A significantly greater decrease in 1,25 (OH)2 Vitamin D was noted with FCM. Several markers of bone turnover significantly changed following administration of FCM but not FDI.ConclusionsThe study suggests a differential effect on FGF23 following administration of FCM compared to FDI in non-dialysis-dependent CKD patients, similar to other patient groups. This may lead to changes consistent with hypovitaminosis D and alterations in bone turnover with potential clinical consequences. Further definitive studies are required to understand these differences of intravenous iron compounds.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials Database (EudraCT) number: 2019–004370-26 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004370-26/GB) (First date of trial registration: 03/12/2019).

Role of preoperative dexamethasone nebulization versus ketamine nebulization in reducing complications of nasogastric tube after laparoscopic surgery

Background &amp; objective: Nasogastric (NG) tube insertion is a frequently performed medical procedure. Most of the time, the oropharyngeal discomfort is usually underestimated, and insertions are carried out with just regular lubricant jelly and no additional painkillers, which results in less-than-ideal pain management. We compared the effectiveness of preemptive use of nebulized ketamine and dexamethasone in preventing post-operative sore throat following NG tube insertion in laparoscopic surgery.&#x0D; Methods: This prospective randomized double-blind controlled study was carried on 108 patients of both sexes with ASA physical status I-II. aged 20-60 years, undergoing laparoscopic abdominal surgeries under general anesthesia. Patients were randomized into 3 equal groups. Group D received a dose of 8 mg nebulized dexamethasone. Group K received 50 mg nebulized ketamine. Group S received 5 ml of nebulized saline. NG tube was passed after induction of general anesthesia. Postoperative sore throat was enquired from the patients at full recovery (zero hour), then at 2, 8, 12 and 24 h. Computer software (SPSS 15.0.1. for Windows; SPSS Inc, Chicago, IL, 2001) was used for data analysis. Non-parametric quantitative data, median, range, percentages, and numbers are given for qualitative data. The appropriate analysis was conducted in line with the data obtained. P &lt; 0.05 was regarded as significant.&#x0D; Results: The incidence of postoperative sore throat (POST) was lower with both nebulized dexamethasone and nebulized ketamine compared with nebulized saline; and significantly lower with dexamethasone compared with ketamine at 0 h (P &lt; 0.001), 2 h (P &lt; 0.001), 8 h (P &lt; 0.001), 12 h (P &lt; 0.001), and 24 h (P &lt; 0.001).&#x0D; Conclusion: The current study revealed that preoperative nebulized dexamethasone was more effective than nebulized ketamine in reducing postoperative sore throat.&#x0D; Abbreviations: NG- Nasogastric; NMDA- N-Methyl-D-Aspartate; PONV- Postoperative Nausea and Vomiting; POST- Postoperative Sore Throat; VAS- Visual Analogue Scale&#x0D; Key words: Nebulization; Dexamethasone; Ketamine; Laparoscopic Surgery; Nasogastric Tube&#x0D; Citation: Zakaria MM, Mohammed Aboulella SK, Hassanein SMK, Elsayed El Hennawy AM, Salah El Din Shabana TS. Role of preoperative dexamethasone nebulization versus ketamine nebulization in reducing complications of nasogastric tube after laparoscopic surgery. Anaesth. pain intensive care 2024;28(1):62-67.&#x0D; DOI: 10.35975/apic.v28i1.2275&#x0D; Received: 22 July, 2023; Reviewed: 04 October 2023; Accepted: 30 October 2023

COMPARISON OF LEVOBUPIVACAINE WITH TWO DIFFERENT ADJUVANTS (DEXAMETHASONE VS. DEXMEDETOMIDINE) IN ULTRASONOGRAPHY-GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK FOR UNILATERAL INGUINAL HERNIORRHAPHY: A RANDOMIZED DOUBLE-BLINDED CONTROL TRIAL

Objectives: Ultrasonography (USG)-guided transversus abdominis plane (TAP) block is an effective technique for postoperative analgesia in patients undergoing intraabdominal surgery. This study was aimed to compare the post-operative analgesia, hemodynamic variables, sedation, and adverse effects of levobupivacaine with two different adjuvants (dexamethasone and dexmedetomidine) in USG-guided TAP block for patients undergoing unilateral inguinal herniorrhaphy under subarachnoid block. Methods: A double-blind randomized control study, conducted on 96 patients, allocated in three groups of 32 each. Patients in group C received 0.25% levobupivacaine (20 mL) with normal saline (2 mL), group D1 received 0.25% levobupivacaine (20 mL) added with 0.1 mg/kg dexamethasone (2 mL) and group D2 received 0.25% levobupivacaine added with 0.5 mcg/kg dexmedetomidine diluted in NS (2 mL). Pain was assessed using Visual Analog Scale (VAS). The time for request of first analgesia (TFA), total number and total dose of rescue analgesic in 24 h were recorded. Statistical analysis was done using unpaired Student’s t-test and ANOVA. Results: At 12 and 24 h &gt;30% of patients had VAS ≥4 in control group while it was &lt;10% in groups D1 and D2 (p&lt;0.001). TFA was earliest in control group (6.10±0.96 h) as compared to group D1 (7.26±1.22 h) and group D2 (7.49±1.02 h) (p&lt;0.001). The total number and total dose of analgesic given were higher in the control group than other two groups (p&lt;0.001). However, it was comparable between groups D1 and D2 (p&lt;0.05). Conclusion: Dexamethasone and dexmedetomidine when added as an adjuvant to levobupivacaine for TAP significantly prolonged the duration of post-operative analgesia as compared to levobupivacaine alone, however, it was found to be comparable between adjuvant groups.

Comparison of oral olanzapine versus oral ondansetron for prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy under general anaesthesia

Introduction: Postoperative nausea and vomiting is one of the significant problem in anaesthesia practice The incidence is even high following laparoscopic surgeries. 5HT3 receptor antagonists are routinely used to prevent postoperative nausea and vomiting (PONV). Olanzapine, an atypical antipsychotic drug with its activity on multiple receptor sites particularly at D2 and 5HT3 receptors, has potential antiemetic properties. This study aimed to compare the efficacy of ondansetron with olanzapine in prevention of PONV following laparoscopic cholesystectomy under general anaesthesia. Materials and methods: This randomized double blind controlled study was done by recruiting 120 female patients belonging to ASA I/II posted for laparoscopic cholecystectomy under general anaesthesia. Patients were assigned to one of the two groups. Group A received tablet Olanzapine 5mg, 4 hrs before surgery and Group B received tablet ondansetron 16mg 1hr before surgery. Postoperatively nausea, retching, vomiting complete response and sedation were assessed for 24hrs at the interval of 0-4hrs, 4-8hrs, 8-12hrs and 12-24hrs. Results: There was no statistical difference in the incidence of postoperative nausea, retching and vomiting between the groups at 0-4hrs, 4-8hrs. Statistical difference between the groups were seen at 8-12hr interval (nausea p=0.048, retching=0.042, vomiting p=0.042) and at 12-24 hr (nausea p=0.028, retching p=0.001, vomiting p=0.006). There was a significant difference in the use of rescue drug at 8-12hrs (6.7% patients required rescue drug in Group B whereas none required in Group B). Conclusion: Olanzapine 5 mg can be used safely and effectively for prophylaxis against PONV and is more effective in preventing PONV during the late postoperative period compared to ondansetron.

Evaluation of Preventive Effect of Zinc Lozenge on Sore Throat after Placement of ProSeal Laryngeal Mask Airway: A Randomised Controlled Study

Introduction: Postoperative Sore Throat (POST) is a known complication after general anaesthesia with an endotracheal tube (14.4% to 50%) and less so with Supraglottic Airway (SGA) devices (5.8% to 34%). Various modalities and drugs can decrease POST. Zinc possesses anti-inflammatory and antioxidant properties and is utilised in oral mucositis and xerostomia. Aim: To evaluate the effect of preoperative administration of a zinc lozenge on POST after the removal of the Proseal Laryngeal Mask Airway (PLMA). Materials and Methods: In this randomised, double-blinded controlled study was conducted at the Department of Anaesthesia at Pt. BD Sharma PGIMS, Rohtak, Haryana, India, over a period of five months from August 2020 to December 2020. 100 patients aged 18-60 years of either sex belonging to American Association of Anesthesiologists (ASA) I and II undergoing elective surgery under general anaesthesia with PLMA placement were randomly allocated into two groups to receive a 40 mg zinc lozenge (Group-I) or placebo (Group-II) and were asked to chew it 30 minutes preoperatively. Patients with upper respiratory tract infections, at risk of aspiration, or with anticipated difficult intubation were excluded from the study. The incidence and severity of POST were assessed on a 4-point scale (0-3) at 30 minutes, 2, 4, and 24 hours postoperatively. The primary outcome of the study was the incidence of POST at four hours postoperatively, and the secondary outcome was the severity of POST at 30 minutes, two hours, and 24 hours postoperatively. Statistical analysis was conducted using Statistical Package for Social Sciences (SPSS) version 20.0 (IBM SPSS Statistics Inc., Chicago, Illinois, USA) Windows software programme. The Chi-square test and unpaired t-test were used for statistical analysis. Results: The mean age in Group-I was 38.6±12.32 years and in Group-II was 37.90±14.84 years (p-value 0.79). Data regarding the distribution of patients according to sex were comparable with a p-value of 0.31. There was a significantly lower incidence of POST in Group-I (zinc group) than in Group-II (placebo group) at four hours with a p-value of 0.004. Conclusion: The present study has shown that the preoperative administration of a 40 mg zinc lozenge effectively reduces the incidence and severity of POST in the postoperative period, peaking at four hours after general anaesthesia. Zinc lozenges are easy, convenient, non invasive, and successfully prevent POST.

The effect of preemptive intravenous ibuprofen for pain relief during hysterosalpingography in women with infertility: A randomized, double-blind controlled study

Objectives: HSG is an invasive diagnostic procedure that involves the radiographic evaluation of the genital system after the injection of a radiopaque substance from the cervical canal in infertile women. Preemptive intravenous ibuprofen is commonly used for postoperative pain management. However, only a limited number of studies have reported the intravenous use of ibuprofen for short-term painful procedures. This study aimed to investigate the effectiveness of intravenous ibuprofen for pain management during HSG. Materials and methods: A total of 91 patients planned to undergo HSG due to infertility were included in the prospective, randomized, double-blind study. Patients were assigned into two groups: the ibuprofen group (group I, n = 43) and the control group (group C, n = 48). About 30 min before the procedure, 800 mg ibuprofen in 100 ml saline infusion was administered to the ibuprofen group, whereas 100 ml saline infusion was administered to the control group 30 min before the starting the procedure. Pain scores using a visual analog scale (VAS) during the procedure were evaluated at four-stage; (1) insertion of the speculum (2) holding and traction (3) administration of contrast matter; and (4) 30 min after the procedure. Besides, the patients were evaluated according to a scale with a range of 1–4 in terms of satisfaction. Results: There was no statistically significant difference in terms of demographic data (p&gt;0.05). VAS pain scores in the median (25%-75%) during the administration of contrast agent were lower in group ibuprofen (median, 1; range 1-2) than in group control (median, 5.5; range 5-6) (p&lt;0.001). There was no statistically significant difference between groups in terms of pain scores other stages of HSG (p&gt;0.05). Patient satisfaction was significantly higher in group ibuprofen than in group control (p&lt;0.001). Conclusion: Intravenous ibuprofen can be administered as an alternative approach to decrease pain and increase patient satisfaction in the HSG procedure performed under outpatient conditions. In conclusion; to the best of our knowledge, this is the first study that administered intravenous ibuprofen in the HSG procedure. However, further studies are needed to compare its effectiveness.

Safety and Efficacy of Nebulised Dexmedetomidine as an Adjuvant to Topical Anaesthesia in Patients Undergoing Endobronchial Ultrasound under Moderate Sedation: A Randomised Double-blinded Controlled Study

Introduction: Anaesthetic sedatives are widely used for bronchoscopy and Endobronchial Ultrasound (EBUS) to ensure patient cooperation and minimise patient discomfort. Dexmedetomidine is an α2 adrenergic agonist used for sedation. Aim: To evaluate the safety and efficacy of nebulised dexmedetomidine in EBUS. Materials and Methods: In this randomised doubleblinded controlled study, conducted in the Department of Anaesthesiology and Pulmonary Medicine at Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India from 2020 to 2022, 52 patients aged between 18 and 70 years undergoing EBUS were included. Patients were randomly assigned to the study group (S) and the control group (C). Group C received nebulised lidocaine (2%) 10 mL for 10- 15 minutes in a sitting position. Group S received nebulised lidocaine (2%) 8 mL + Dexmedetomidine 2 mL (1 mcg/kg) for 10-15 minutes in a sitting position. Haemodynamic parameters, cough severity scores, patient and operator satisfaction scores, Midazolam requirements, and any complications were recorded and compared. The data were analysed statistically using the Student’s t-test and Chi-square test, whichever was feasible. A p-value of &lt;0.05 was considered statistically significant. Results: The demographic parameters including the mean age (years) of 46.3±14.01 in Group C vs. 44.5±14.35 in Group S, mean weight (kg) of 61.6±8.27 in Group C vs. 63.5±10.06 in Group S, and male/female ratio of 12/14 in Group C vs. 9/17 in Group S were comparable. Haemodynamic parameters were better postnebulisation in Group S compared to Group C. The authors observed that the incidence of coughing was significantly higher in Group C compared to Group S (73.1% vs. 46.2%). It was found that Group C had a significantly higher requirement for midazolam doses compared to Group S (53.8% vs. 19.2%). When the patient satisfaction score assessed on the Numerical Rating Scale (NRS) was analysed, it was found that Group S patients were highly satisfied compared to Group C patients, and the difference was highly significant (p-value &lt;0.05). No drug or procedure-related complications were observed in the two groups. Conclusion: The present study demonstrated that nebulised dexmedetomidine-lidocaine was well-tolerated during bronchoscopies under moderated sedation and was associated with stable Haemodynamics, decreased incidence of severe coughing, and a lower consumption of sedation drugs.

Comparison of Dexmedetomidine and Fentanyl Added to Levobupivacaine in USG-guided Axillary Block for Upper Limb Surgeries: A Randomised Double-blinded Controlled Study

Introduction: Apart from general anaesthesia, brachial plexus block by the axillary approach is one of the reliable sole anaesthetic techniques for patients undergoing upper limb surgeries. In this study, levobupivacaine was chosen due to fewer adverse effects compared to Bupivacaine, and fewer studies were available for the axillary approach to brachial plexus block. Adjuvants were added to hasten the onset and also to prolong their analgesic effect. Aim: To compare the effect of Dexmedetomidine (D) 0.5 mcg/kg and Fentanyl (F) 0.5 mcg/kg when added to 0.5% Levobupivacaine (L) as an adjuvant in brachial plexus block by the axillary approach for upper limb surgeries. Materials and Methods: A randomised double-blind controlled study was carried out at the Department of Anaesthesiology, Sree Balaji Medical College, BIHER, Chennai, Tamil Nadu, India from January 2020 to October 2021 on 60 American Society of Anaesthesiologists (ASA) I and II patients of either sex posted for various types of upper limb surgeries. Subjects were divided into two equal groups by computer-generated randomisation. Group A received 0.5% levobupivacaine and dexmedetomidine 0.5 mcg/kg, and Group B received 0.5% levobupivacaine and Fentanyl 0.5 mcg/kg. Both patients and the evaluator were unaware of the type of adjuvants added to the local anaesthetic. The onset time, duration of sensory and Motor blockade were recorded. Haemodynamic variables and duration of analgesia were recorded for 24 hours postoperatively. The Mann-Whitney U test demonstrated variations in the onset and duration of sensory and motor blocks. Adverse effects, including nausea, vomiting, and hypotension, exhibited significant differences according to Fisher’s-exact test. Results: Age and weight distributions were comparable between groups (mean age: Group A=45.20 years, Group B=44.80 years; mean weight: Group A=74.13 kg, Group B=74.43 kg). Group A exhibited faster sensory and motor block onset times (sensory: Group A=6.20 minutes, Group B=8.63 minutes; motor: Group A=8.27 minutes, Group B=10.00 minutes), longer block durations (sensory: Group A=11.63 hours, Group B=9.53 hours; motor: Group A=9.67 hours, Group B=8.20 hours), and required the first rescue analgesic (Group A=12.57 hours, Group B=10.27 hours) compared to Group B (p&lt;0.05). Similarly, the mean time for the first rescue analgesia for patients among these two groups was also statistically significant (p&lt;0.05). Conclusion: The addition of 0.5 mcg/kg dexmedetomidine to 0.5% levobupivacaine in axillary block was more effective in prolonging the duration of blockade and providing adequate intraoperative analgesia when compared to 0.5 mcg/kg fentanyl with 0.5% levobupivacaine, without producing any adverse events.

A prospective, single-centre, randomized, double-blind controlled study protocol to study whether long-term oral metronidazole can effectively reduce the incidence of postoperative liver metastasis in patients with colorectal cancer

IntroductionFifteen to 25% of patients with colorectal cancer have combined liver metastases at the time of diagnosis, whereas an additional 15 to 25% will develop liver metastases after curative resection of primary colorectal cancer, with the vast majority (80–90%) of liver metastases unresponsive to curative resection at first. Colorectal cancer liver metastasis is also the leading cause of death in patients with colorectal cancer. In recent years, several studies have demonstrated that intestinal flora, especially Fusobacterium nucleatum, plays a crucial role in the development of colorectal cancer liver metastasis, so we hypothesized that long-term metronidazole use could effectively reduce the incidence of postoperative liver metastasis in colorectal cancer patients.Methods/designThis study is a prospective, single-centre, randomized, double-blind controlled study in which 300 patients will be randomly assigned to the test group or the control group in a 1:1 allocation ratio. The aim of this trial is to demonstrate that long-term oral antibiotics can effectively reduce the incidence of postoperative liver metastasis in patients with colorectal cancer.Ethics and disseminationEthics approval was obtained from the Ethics Committee at the Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT20210229). The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals.Trial registrationChinese Clinical Trial Registry ChiCTR2100046201. Registered on July 05, 2021.

Efficiency of face mask ventilation before and after neuromuscular blockade: A randomised, double-blind controlled study.

The traditional practice of administrating neuromuscular blocking drugs (NMBDs) after checking face mask ventilation is challenged repeatedly. This study compared the efficiency of face mask ventilation before and after administrating an NMBD in a patient with a normal airway. The secondary outcome measured was the grade of mask ventilation and tracheal intubating conditions. After ethical approval, patients (n = 120) in the age group of 18-65 years scheduled for elective surgery under general anaesthesia were randomly assigned into two groups. Group 1 received an NMBD before checking face mask ventilation. Group 2 received an NMBD after checking face mask ventilation. Lungs were ventilated for 180 s, during which expiratory tidal volume (Vte) was recorded as the primary outcome. Hans's grading for face mask ventilation was used to grade mask ventilation. The ease of intubation was assessed based on intubating conditions (ease of laryngoscopy, vocal cord movement, and limb movement). SPSS 20.0 software was used for statistical analysis. For a total of 180 seconds of mask ventilation, the mean (standard deviation) Vte measured after apnoea was significantly higher in Group 1 versus Group 2 [471.9 (63.3) vs 434.8 (77.0) mL/breath, P = 0.004]. The intubating condition was either excellent or good in all patients. The administration of NMBDs resulted in a larger mask Vte and shorter intubation time.

Clinical efficacy of local infiltration of lidocaine and tranexamic acid application in tonsillar region on postoperative pain and bleeding during tonsillectomy: prospective, randomized, double-blind controlled study

BackgroundAnesthetic techniques are designed to minimize intraoperative surgical bed bleeding which is a major problem that may interfere with precision, surgery duration, or postoperative wound healing. The main reason for reoperation and/or mortality in children who have had tonsillectomies is post-tonsillectomy hemorrhage. We evaluate the local application effect of tranexamic acid and lidocaine local infiltration in the tonsillar bed during tonsillectomy surgery on postoperative analgesia and bleeding.ResultsFLACC scores showed a statistically significant reduction in the first 24 h in group T (P < 0.05). Post-tonsillectomy hemorrhage was significantly minimized in group T. No complications were recorded following the local application of tranexamic acid and local lidocaine infiltration inside the tonsil bed.ConclusionsLocal infiltration of lidocaine provides adequate postoperative analgesia, and tranexamic acid application during tonsillectomy surgery minimizes postoperative bleeding and shortens surgery duration.Trial registrationThis study was preregistered with the Clinical Trials Registry (NCT05817474).

Clonidine premedication in spinal anaesthesia: Effect on hemodynamic status and vasopressor response to ephedrine

Introduction: Premedication has an important role to play in modern day anaesthesia care. In recent years, clonidine is making a comeback as a premedicant. Our study deals with haemodynamic changes to ephedrine after oral clonidine premedication for spinal anaesthesia with or without concurrent administration of drugs.The purpose of the study is to know the effect of oral clonidine premedication on haemodynamic status including vasopressor response of ephedrine during spinal anaesthesia. Materials: This is a prospective randomized double blinded controlled study. Sixty adult patients belonging to ASA I scheduled for elective surgery under spinal anaesthesia were selected. The patients were randomly assigned to 2 groups.Oral clonidine 4 microgram/kg was administered to group A(Clonidine group, n equal to 30) and 90 and one tablet of vitamin (placebo) orally 90 minutes was administered to group B (Control group, n equal to 30)90 minutes prior to anaesthesia. On the morning of surgery, blood pressure was measured before premedication and 90 minutes later. Sedation and anxiolysis were scored during clonidine premedication and 90th minute afterwards. When SBP decreased to 80% of the pre-spinal value, bolus IV injection of ephedrine 0.1 mg/kg was administered. After ephedrine injections, blood pressure and heart rate were recorded at 1 minute interval for 10 minutes. Results: Group A patients were found to have low SBP, DBP, MBP and HR when compared to group B. Intravenous ephedrine augmented blood pressure more than the control group. Statistically significant difference was found for SBP after 5 minutes, for MBP after 4 minutes of ephedrine administration and no significant difference was found for DBP. Conclusion: We conclude from our study that clonidine administered orally in a dose of 4 microgram/kg as a premedicant increases the pressor responses to IV injection ephedrine 0.2 mg/kg in patients with subarachnoid block.

Analgesic efficacy of intra-peritoneal instillation of dexamethasone and bupivacaine versus bupivacaine following laparoscopic cholecystectomy – A randomised, double-blind controlled study

Background and Aims: Laparoscopy is associated with acute pain. We compared the effectiveness of intra-peritoneal dexamethasone with bupivacaine versus bupivacaine in patients undergoing laparoscopic cholecystectomy for postoperative analgesia. Methods: This randomised study was conducted after approval from the institutional ethics committee and 84 patients were randomly allocated into bupivacaine with dexamethasone group (BD) (received 40 mL of 0.25% bupivacaine with 16 mg dexamethasone), and bupivacaine group (BB) (received 40 mL of 0.25% bupivacaine intra-peritoneally). Data analysis was done using R version 4.2.1. The visual analogue scale (VAS) score, total rescue analgesic dose, and time required for the first analgesic between groups were compared using the Wilcoxon rank sum test or t-test appropriately. Results: VAS score was significantly lower in the BD group compared to the BB group until 2 h post-operatively with a mean difference of − 1.0 (95% confidence interval [CI] −1.5, −0.53), P &lt; 0.001. The total rescue analgesic dose consumed was lower in the BD group (60.71 mg [29.80]) compared to the BB group (73.20 mg [11.57]) with a mean difference of − 12.5 mg (95% CI − 22.3, −2.68), P = 0.013. In addition, the time taken for the requirement of the first rescue analgesic was significantly longer in the BD group (417.1 min [276.0]) compared to the BB group (219.4 min [226.1]) with a mean difference of 197.7 (95% CI 75, 320), P = 0.002. Conclusion: Intra-peritoneal instillation of 16 mg dexamethasone with 0.25% bupivacaine in laparoscopic cholecystectomy significantly reduces post-operative pain and requirement of rescue analgesic compared to 0.25% bupivacaine alone.