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Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy

RecruitingNAAges 18 Years - 60 YearsAllArmed Forces Medical Institute Bangladesh
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18-60 years * American Society of Anesthesiologists (ASA) physical status I-II * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * Able to understand and provide informed consent * Willing to participate in the study and complete follow-up assessments * Body mass index (BMI) 18-35 kg/m2 Exclusion Criteria: * Known allergy or hypersensitivity to melatonin or placebo component * Chronic use of opioids, sedatives, or hypnotics (regular use for โ‰ฅ4 weeks prior to surgery) * Current use of beta-adrenergic receptor antagonists (beta-blockers) (suppress endogenous melatonin secretion via inhibition of pineal ฮฒโ‚-adrenergic receptors) * History of psychiatric disorders requiring ongoing pharmacological treatment * Pregnancy or lactation * Severe hepatic impairment (Child-Pugh class B or C), as melatonin undergoes extensive first-pass hepatic metabolism via CYP1A2 * Diagnosed obstructive sleep apnoea requiring continuous positive airway pressure * Diagnosed circadian rhythm disorder (e.g., delayed sleep phase disorder, advanced sleep phase disorder) requiring medical management * Use of exogenous melatonin supplements within 30 days prior to surgery * Inability to complete study questionnaires due to language barrier or cognitive impairment * History of substance abuse or dependence
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What it tests

  • Melatonin (N-acetyl-5-methoxytryptamine)
  • Placebo
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Where

1 site
Department of Anaesthesiology, Combined Military Hospital, Dhaka Cantonment,Dhaka
Dhaka, Bangladesh
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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