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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02424071
Enrollment
60
Registered
2015-04-22
Start date
2015-07-31
Completion date
2016-04-30
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery From Bariatric Surgery

Keywords

melatonin's, quality of recovery

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.

Interventions

DRUGMelatonin
DRUGplacebo

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing bariatric surgery

Exclusion criteria

* Known allergy to melatonin

Design outcomes

Primary

MeasureTime frame
Quality of recovery after surgeryFirst post operative day

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026