Melatonin in Obese Patients in Laparoscopic Cholecystectomy

The Evaluation of Adding Melatonin to Opioid Free Anesthesia on Postoperative Pain in Obese Patients Undergoing Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Melatonin; Dietary supplement: Vitamin Supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismail FA Ibrahim, MSc; Phone Number: 00201008092950; Email: ismail.mahmoud@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Melatonin; Obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia.; Other Names: Circadin
Placebo Comparator: 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.	Dietary supplement: Vitamin Supplement; Obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at time of 30 minutes after delivery to PACU and hourly for 4 hours.
Analgesics usage.	The total dose of analgesics consumption was used postoperatively per patient rescue analgesia.	Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.
Postoperative nausea and vomiting.	The occurrence of postoperative complications including postoperative nausea and vomiting.	Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.
Recovery time.	The time between patient admission to PACU and being discharged from it.	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.	Intraoperative hemodynamic stability data (Systolic blood pressure; in mmHg, Diastolic blood pressure; in mmHg, and Mean arterial pressure; in mmHg)	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.
Number of participants with hemodynamic instability.	Intraoperative hemodynamic stability data (Heart rate; in beats per second)	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.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: April 6, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: FMASU MD304/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No