MEL-REC: Melatonin for Quality of Recovery After Laparoscopic Cholecystectomy RCT
ClinicalTrials.gov Studies
Summary
The MEL-REC trial is a prospective, randomized, double-blind, placebo-controlled Phase 4 study registered on ClinicalTrials.gov (NCT07553143) evaluating preoperative oral melatonin versus placebo for quality of recovery in 60 patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The study is conducted by the Department of Anaesthesiology at Combined Military Hospital (CMH), Dhaka, Bangladesh, with an 18-month total study period (January 2026 to June 2027) and 8-month recruitment window (May to December 2026). Co-primary endpoints include QoR-15 scores at 24 hours post-surgery; secondary endpoints include sleep quality, anxiety, opioid consumption, PONV, and fatigue through day 7.
“Melatonin, an endogenous hormone that regulates circadian rhythm, also possesses anxiolytic, analgesic, antioxidant, and anti-inflammatory properties, positioning it as a valuable perioperative adjunct.”
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This ClinicalTrials.gov registration documents a new prospective RCT, the MEL-REC trial (NCT07553143), investigating whether preoperative oral melatonin (5 mg administered the night before and 1–2 hours preoperatively) improves quality of recovery in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The study employs a double-blind, placebo-controlled design enrolling 60 patients at Combined Military Hospital, Dhaka, Bangladesh, with a primary endpoint of QoR-15 scores at 24 hours post-surgery.
The trial registration provides public transparency on the study design, eligibility criteria, interventions, and outcome measures. Healthcare institutions and clinical investigators conducting perioperative research or Enhanced Recovery after Surgery (ERAS) programs may use this registration to stay informed about ongoing investigations into melatonin as an adjunct therapy for surgical recovery, particularly in South Asian clinical settings where data remain limited.
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Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
N/A NCT07553143 Kind: NA Apr 27, 2026
Abstract
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.
This 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 D...
Conditions: Laparoscopic Cholecystectomy, Postoperative Quality of Recovery, Preoperative Anxiety, Postoperative Sleep Quality, Opioid Consumption, Postoperative, PONV in Laparoscopic Cholocystectomies
Interventions: Melatonin (N-acetyl-5-methoxytryptamine), Placebo
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