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NCT02424071 Clinical Trial

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

Recovery From Bariatric Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02424071
Other study ID # SHEBA-2015-1841-HB-CTIL
Secondary ID
Status Completed
Phase Phase 4
First received April 19, 2015
Last updated April 25, 2017
Start date July 2015
Est. completion date April 2016

Study information
Verified date April 2017
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients undergoing bariatric surgery

Exclusion Criteria:

- Known allergy to melatonin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Melatonin

• placebo

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of recovery after surgery First post operative day

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