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

NCT ID
NCT07553143
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Armed Forces Medical Institute Bangladesh
Conditions
Laparoscopic Cholecystectomy, Opioid Consumption, Postoperative, PONV in Laparoscopic Cholocystectomies, Postoperative Quality of Recovery, Postoperative Sleep Quality, Preoperative Anxiety

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Enrollment: 84 participants (Estimated).

What is being studied

  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 2-Ring
  • Intervention: Heterocyclic Compounds, Fused-Ring
  • Intervention: Hormones
  • Intervention: Hormones, Hormone Substitutes, and Hormone Antagonists
  • Intervention: Indoles
  • Intervention: Melatonin
  • Drug: Melatonin (N-acetyl-5-methoxytryptamine)
  • Drug: Placebo
  • Intervention: Tryptamines

Who may be eligible

Ages
18 Years to 60 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Bangladesh

  • Dhaka Division, Bangladesh: 1

Sample of listed locations

  • Department of Anaesthesiology, Combined Military Hospital, Dhaka Cantonment,Dhaka — Dhaka, Dhaka Division, 1206, Bangladesh — Recruiting

Study details

Start date
May 1, 2026
Primary completion date
December 31, 2026
Completion date
June 30, 2027
First posted
April 27, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07553143
Registry last updated
September 30, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07553143 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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