The Effect of Premedication With Melatonin on Postoperative Recovery From Bariatric Surgery

Phase 4

Completed

• Conditions: Recovery From Bariatric Surgery
• Interventions: Drug: placebo; Drug: Melatonin

• Registration Number: NCT02424071
• Lead Sponsor: Sheba Medical Center

Brief Summary

Melatonin has sedative, hypnotic and analgesic properties that make it a good premedication agent before anesthesia and surgery.

In this study the investigators intend to randomise 60 patients undergoing bariatric surgery into two groups. The participants will receive either melatonin or placebo on the evening prior to the surgery, and the same agent two hours before the surgery.

The patients recovery from the surgery and anesthesia will be assessed using the Q0R15 questionnaire. The patients will be asked to take the questionnaire once in the pre-operative clinic, again after the second melatonin or placebo pill before entering the operating room, and once more on the first post-operative day.

Detailed Description

Melatonin has sedative, hypnotic, analgesic, antiinflammatory, and chronobiologic properties that make it a good premedication agent before anesthesia and surgery. Patients undergoing surgery in our establishment usually receive benzodiazepines as premedicants to reduce anxiety before the surgery. For bariatric patients benzodiazepines are usually avoided due to side effects which could be deleterious in obese patients.

In this study the investigators intend to randomise 60 patients undergoing bariatric surgery into two groups. The participants will receive either melatonin or placebo on the evening prior to the surgery, and the same agent two hours before the surgery.

The patients recovery from the surgery and anesthesia will be assessed using the Q0R15 questionnaire. The patients will be asked to take the questionnaire once in the pre-operative clinic, again after the second melatonin or placebo pill before entering the operating room, and once more on the first post-operative day.

Study Timeline

• Study First Submitted: 2015-04-19
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Study Start: 2015-07
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing bariatric surgery

Exclusion Criteria

• Known allergy to melatonin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo	Patients will receive a pill containing placebo on the evening before the surgery. Patients will receive another pill containing placebo two hours prior to surgery.
Melatonin group	Melatonin	Patients will receive a pill containing 5mg of melatonin on the evening before the surgery. Patients will receive another pill containing 5mg of melatonin two hours prior to surgery.

Primary Outcome Measures

Name	Time	Method
Quality of recovery after surgery	First post operative day

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel