[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Armed Forces Medical Institute Bangladesh\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100635473","effect-of-preoperative-melatonin-on-quality-of-recovery-after-elective-laparoscopic-cholecystectomy-100635473",false,"NCT07553143","Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy","Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial","MEL-REC","Inclusion Criteria:\n\n* Age 18-60 years\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Scheduled for elective laparoscopic cholecystectomy under general anesthesia\n* Able to understand and provide informed consent\n* Willing to participate in the study and complete follow-up assessments\n* Body mass index (BMI) 18-35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to melatonin or placebo component\n* Chronic use of opioids, sedatives, or hypnotics (regular use for ≥4 weeks prior to surgery)\n* Current use of beta-adrenergic receptor antagonists (beta-blockers) (suppress endogenous melatonin secretion via inhibition of pineal β₁-adrenergic receptors)\n* History of psychiatric disorders requiring ongoing pharmacological treatment\n* Pregnancy or lactation\n* Severe hepatic impairment (Child-Pugh class B or C), as melatonin undergoes extensive first-pass hepatic metabolism via CYP1A2\n* Diagnosed obstructive sleep apnoea requiring continuous positive airway pressure\n* Diagnosed circadian rhythm disorder (e.g., delayed sleep phase disorder, advanced sleep phase disorder) requiring medical management\n* Use of exogenous melatonin supplements within 30 days prior to surgery\n* Inability to complete study questionnaires due to language barrier or cognitive impairment\n* History of substance abuse or dependence","ALL","18 Years","60 Years",{"count":21,"type":22},84,"ESTIMATED","INTERVENTIONAL",[25],"NA","Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures worldwide. Although the widespread implementation of Enhanced Recovery after Surgery (ERAS) protocols has improved perioperative outcomes, many patients continue to experience postoperative pain, sleep disturbance, anxiety, nausea, and fatigue, symptoms that collectively impair overall quality of recovery (QoR). Melatonin, an endogenous hormone that regulates circadian rhythm, also possesses anxiolytic, analgesic, antioxidant, and anti-inflammatory properties, positioning it as a valuable perioperative adjunct. However, most previous studies have evaluated melatonin primarily for isolated outcomes such as sleep quality or anxiety. Its effect on comprehensive postoperative recovery, assessed using validated patient-reported outcome instruments, remains insufficiently explored, particularly in laparoscopic cholecystectomy populations and in South Asian clinical settings.\n\nThis prospective, randomized, double-blind, placebo-controlled trial (the MEL-REC trial) aims to evaluate the effect of preoperative oral melatonin on postoperative quality of recovery in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The study will be conducted in the Department of Anaesthesiology at Combined Military Hospital (CMH), Dhaka, Bangladesh, over a total study period of 18 months (January 2026 to June 2027), with patient recruitment planned for 8 months (May to December 2026) after taking approval from institutional review board. Eighty four adult patients aged 18-60 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly allocated in a 1:1 ratio into two equal groups (n = 42 per group) using computer-generated permuted block randomization with centralized pharmacy based allocation concealment. The melatonin group (Group M) will receive oral melatonin 6 mg administered 60 minutes before induction of anaesthesia and the placebo group (Group P) will receive an identical placebo tablet under the same conditions. Neither the participants, the treating anaesthesiologist, the outcome assessor, nor the data analyst will be aware of group allocation until database lock. All patients will receive a standardized anaesthesia and perioperative management protocol, including standardized postoperative analgesia.\n\nThe primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) score at 24 ± 2 hours after surgery. Secondary outcomes include postoperative sleep quality measured by the Richards-Campbell Sleep Questionnaire, change in preoperative anxiety (delta-VAS-A score), total opioid consumption during the first 24 hours expressed as intravenous morphine milligram equivalents, incidence of postoperative nausea and vomiting, and time to first rescue analgesic request. All postoperative outcomes will be assessed by a trained research assistant blinded to group allocation.\n\nBased on the available evidence, it is anticipated that patients receiving preoperative melatonin will demonstrate higher QoR-15 scores at 24 hours after surgery compared with the placebo group. The melatonin group is also expected to have improved postoperative sleep quality, reduced opioid consumption, and a greater reduction in preoperative anxiety.\n\nIf a clinically meaningful benefit is confirmed, given its well established safety profile, low cost, and ease of oral administration, preoperative melatonin may represent a practical perioperative adjunct that can be readily incorporated into ERAS protocols for laparoscopic cholecystectomy. The trial will be prospectively registered in the Bangladesh Medical Research Council (BMRC) clinical trial registry or clinicaltrials.gov prior to recruitment.",[28,29,30,31,32,33],"Laparoscopic Cholecystectomy","Postoperative Quality of Recovery","Preoperative Anxiety","Postoperative Sleep Quality","Opioid Consumption, Postoperative","PONV in Laparoscopic Cholocystectomies",[29,35,36,28],"QoR-15","Melatonin","NOT_YET_RECRUITING","2026-04-29",{"date":40,"type":41},"2026-05-05","ACTUAL",{"date":43,"type":22},"2026-05-01",{"date":45,"type":22},"2027-06-30",{"name":47,"class":48},"Armed Forces Medical Institute Bangladesh","OTHER",""]