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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Premedication With Melatonin on Postoperative Recovery From Bariatric Surgery: a Prospective Randomised Controlled Cohort Study

Conditions
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Recovery From Bariatric Surgery

Intervention / Treatment
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* Drug: Melatonin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing bariatric surgery Exclusion Criteria: Known allergy to melatonin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin group<br>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. | Drug: Melatonin<br> <br> |
| Placebo Comparator: Placebo group<br>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. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery after surgery |  | First post operative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin's, quality of recovery