The Effect of Premedication With Melatonin on Postoperative Recovery From Bariatric Surgery
NCT ID: NCT02424071
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2015-07-31
2016-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Melatonin group
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.
Melatonin
Placebo group
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.
placebo
Interventions
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Melatonin
placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Haim Berkenstadt
Director of Anesthesia, Sheba medical center
Principal Investigators
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Haim Berkenstadt, MD
Role: STUDY_DIRECTOR
Sheba Medical Center
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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References
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Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials. Anesthesiology. 2010 Oct;113(4):968-76. doi: 10.1097/ALN.0b013e3181e7d626.
Caumo W, Torres F, Moreira NL Jr, Auzani JA, Monteiro CA, Londero G, Ribeiro DF, Hidalgo MP. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007 Nov;105(5):1263-71, table of contents. doi: 10.1213/01.ane.0000282834.78456.90.
Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2(14):i-iv, 1-74. No abstract available.
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
Related Links
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Melatonin NIH fact sheet
Other Identifiers
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SHEBA-2015-1841-HB-CTIL
Identifier Type: -
Identifier Source: org_study_id
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