Does preoperative melatonin improve recovery after gallbladder removal?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the effect of preoperative melatonin versus placebo on postoperative recovery in adults undergoing elective laparoscopic cholecystectomy. Recovery is assessed with the QoR-15, a patient-reported measure spanning comfort, emotions, independence, support, and pain. The trial uses a randomized design and includes adults aged 18–60 with ASA I–II, excluding those with factors that could affect melatonin metabolism or recovery. Outcomes focus on overall quality of recovery, sleep quality, anxiety, and opioid consumption during the early postoperative period. The setting is the Armed Forces Medical Institute Bangladesh at the Combined Military Hospital in Dhaka.

Why it matters

Who can join: the full rules

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 ≥4 weeks prior to surgery)
* Current use of beta-adrenergic receptor antagonists (beta-blockers) (suppress endogenous melatonin secretion via inhibition of pineal β₁-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

Where it's running

• Department of Anaesthesiology, Combined Military Hospital, Dhaka Cantonment,Dhaka
  Dhaka, Dhaka Division, Bangladesh Recruiting

Study contacts

• Study coordinator: Ahsan Habib Noman, Major
• Email: ahsanhabibnoman777@gmail.com
• Phone: +8801769051441

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.