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Completed

NCT Number: NCT02424071

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheba Medical Center

Ramat Gan, 5262100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing bariatric surgery

Exclusion criteria

  • Known allergy to melatonin

Treatment and study plan

Melatonin

Drug

Placebo

Drug

Primary outcomes

  1. Quality of recovery after surgery

    Time frame: First post operative day

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2015
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.