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Melatonin in Obese Patients in Laparoscopic Cholecystectomy

NCT06355687 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-09

No results posted yet for this study

Summary

Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy.

Conditions

  • Anesthesia

Interventions

DRUG

Melatonin

Obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia.

DIETARY_SUPPLEMENT

Vitamin Supplement

Obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Hala GO Salama, MD · Faculty of Medicine, Ain Shams University

  • Reham MU Hashim, MD · Faculty of Medicine, Ain Shams University

  • Walid YO Youssef, MD · Faculty of Medicine, Ain Shams University

  • Diaaeldein MA Haiba, MD · Faculty of Medicine, Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-04-30
Completion
2025-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06355687 on ClinicalTrials.gov