Melatonin in Obese Patients in Laparoscopic Cholecystectomy

NCT06355687 | Not Yet Recruiting

• 1 other identifier: FMASU MD304/2023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain.

  Numeric Rating Scale (NRS); is a pain screening tool, commonly used to assess pain severity at that moment in time using a (0-10) scale, with (0) meaning no pain and (10) meaning the worst pain imaginable.

  Will be evaluated postoperatively at time of delivery to Post Anesthesia Care Unit (PACU) (Zero time) and every 5 minutes for 30 minutes.

Secondary Outcomes (6)

• Postoperative Pain.

  Will be evaluated at time of 30 minutes after delivery to PACU and hourly for 4 hours.

• Analgesics usage.

  Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.

• Postoperative nausea and vomiting.

  Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.

• Recovery time.

  Will be evaluated at time of admission to PACU and every 15 minutes for 1 hour until being discharged from it.

• Number of participants with hemodynamic instability.

  Will be evaluated at the start of the operation and every 5 minutes throughout the operation until delivery to PACU and every 15 minutes for 1 hour until being discharged from it.

Study Arms (2)

The Melatonin group

ACTIVE COMPARATOR

Melatonin group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia.

Drug: Melatonin

The Control group

PLACEBO COMPARATOR

Control group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia; Control group.

Dietary Supplement: Vitamin Supplement

Interventions

Melatonin DRUG

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

Also known as: Circadin

The Melatonin group

Vitamin Supplement DIETARY_SUPPLEMENT

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

The Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-45 years.
• Body Mass Index: Over 30 kg/m2.
• Physical Status: ASA classification I and II.

You may not qualify if:

• Patient refusal.
• Age: Less than 18 years, more than 45 years.
• Patients with known history of allergy towards one of the study drugs.
• Patients with severe cardiac, respiratory, hepatic or renal disease.
• Body Mass Index: Under 30 kg/m2.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Hala GO Salama, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Reham MU Hashim, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Walid YO Youssef, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Diaaeldein MA Haiba, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail FA Ibrahim, MSc

CONTACT

00201008092950; ismail.mahmoud@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04