- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107702
Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.
Relationship Between Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. Melatonin is neurohormone with the profile of a novel hypnotic-anesthetic agent.
The purpose of this study is to investigate the preoperative, perioperative and postoperative melatonin levels in bariatric surgery under general anesthesia and to investigate the relationship between melatonin level and analgesia requirement.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. The hypnotic, antinociceptive, and anticonvulsant properties of melatonin endow this neurohormone with the profile of a novel hypnotic-anesthetic agent.
The purpose of this study is to investigate the preoperative, perioperative and postoperative melatonin levels in bariatric surgery under general anesthesia and to investigate the relationship between melatonin level and analgesia requirement.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Malatya, Turkey, 044100
- İnonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Exclusion Criteria:
Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Melatonin and bariatric surgery
the relationship between melatonin level and analgesia requirement.
|
the relationship between melatonin level and analgesia requirement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Melatonin Level
Time Frame: Change from Baseline melatonin at postoperative 24 hours
|
Melatonin is a hormone secreted from the pineal gland.
It shows a daily biorhythm.
Melatonin level can be measured in the blood and in urine collected for 24 hours.
|
Change from Baseline melatonin at postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine consumption
Time Frame: change from postoperative up to 24 hours
|
Morphine is analgesic agent.
It will used postoperative period
|
change from postoperative up to 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Türkan Toğal, Prof., İnönü University Faculty of Medicine
Publications and helpful links
General Publications
- Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
- Gogenur I, Ocak U, Altunpinar O, Middleton B, Skene DJ, Rosenberg J. Disturbances in melatonin, cortisol and core body temperature rhythms after major surgery. World J Surg. 2007 Feb;31(2):290-8. doi: 10.1007/s00268-006-0256-5.
- Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914.
- Altunkaya N, Erdogan MA, Ozgul U, Sanli M, Ucar M, Ozhan O, Sumer F, Erdogan S, Colak C, Durmus M. Changes in Melatonin, Cortisol, and Body Temperature, and the Relationship Between Endogenous Melatonin Levels and Analgesia Consumption in Patients Undergoing Bariatric Surgery. Obes Surg. 2018 Oct;28(10):3186-3192. doi: 10.1007/s11695-018-3313-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAE5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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