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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06355687
Enrollment
60
Registered
2024-04-09
Start date
2024-04-30
Completion date
2025-04-30
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGMelatonin

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

DIETARY_SUPPLEMENTVitamin Supplement

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Postoperative Pain.Will be evaluated at time of 30 minutes after delivery to PACU and hourly for 4 hours.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.
Analgesics usage.Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.The total dose of analgesics consumption was used postoperatively per patient rescue analgesia.
Postoperative nausea and vomiting.Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.The occurrence of postoperative complications including postoperative nausea and vomiting.
Recovery time.Will be evaluated at time of admission to PACU and every 15 minutes for 1 hour until being discharged from it.The time between patient admission to PACU and 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.Intraoperative hemodynamic stability data (Systolic blood pressure; in mmHg, Diastolic blood pressure; in mmHg, and Mean arterial pressure; in mmHg)

Contacts

Primary ContactIsmail FA Ibrahim, MSc
ismail.mahmoud@med.asu.edu.eg00201008092950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026