Melatonin in Obese Patients in Laparoscopic Cholecystectomy

NCT ID: NCT06355687

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-04-30

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.

Detailed Description

Obesity leads to a restrictive lung disease, causing reduction in functional residual capacity and total lung compliance.

When an obese patient is supine and anesthetised, the depressant effects of many anesthetic agents and analgesics, particularly opioids, further decrease the lung compliance, leading to increased hypoxemia.

Opioid based general anesthesia in these patients increases the incidence of postoperative respiratory depression, atelectasis, and pneumonia. Also, pain relief with opioids is associated with sedation, hence impeding rapid recovery and early mobilization.

OFA is the use of multimodal or balanced analgesia. The principle of this is to gain additive analgesic effects from different drugs while minimizing side effects, particularly those of opioids. Studies have shown that OFA fast tracks surgery, reduces hospital stay, promotes early mobilization, and enteral nutrition.

Prior studies which investigated opioid free techniques are based on the combination of drugs acting on sympathetic nervous system, perioperative administration of local anesthetics, nonsteroidal anti-inflammatory drugs, and of adjuvant drugs, such as ketamine, magnesium etc.

Laparoscopic surgery is more challenging in obese patients since they have excessive pneumoperitoneal insufflation pressures, longer anesthetic, surgical, and recovery times. Moreover, these procedures are usually done in Trendelenburg position which further leads to increased airway resistance.

Melatonin is mainly secreted from the pineal gland by the suprachiasmatic nucleus. This neurohormone possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting. In addition, melatonin can be used to moderate the effect of light on the autonomic system.

Several studies have reported that melatonin, as an analgesic, anti-inflammatory, anxiolytic, and anti-agitation premedication, is associated with sedation and anxiolysis without adverse effects on recall and driving performance.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

The Melatonin group

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

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

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

The Control group

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

Group Type: PLACEBO_COMPARATOR

Vitamin Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Melatonin

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

Intervention Type: DRUG

Vitamin Supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Circadin

Eligibility Criteria

Inclusion Criteria

1. Age: 18-45 years.

2. Body Mass Index: Over 30 kg/m2.

3. Physical Status: ASA classification I and II.

Exclusion Criteria

1. Patient refusal.

2. Age: Less than 18 years, more than 45 years.

3. Patients with known history of allergy towards one of the study drugs.

4. Patients with severe cardiac, respiratory, hepatic or renal disease.

5. Body Mass Index: Under 30 kg/m2.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ismail Farid Ibrahim Mahmoud

Assistant Lecturer of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala GO Salama, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Reham MU Hashim, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Walid YO Youssef, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Diaaeldein MA Haiba, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Central Contacts

Ismail FA Ibrahim, MSc

Role: CONTACT

ismail.mahmoud@med.asu.edu.eg

00201008092950

Other Identifiers

FMASU MD304/2023

Identifier Type: -

Identifier Source: org_study_id