Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.

Sponsor
Inonu University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03107702
Collaborator
(none)
35
1
4
8.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: melatonin

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 Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Relationship Between Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.
Actual Study Start Date :
Mar 29, 2017
Anticipated Primary Completion Date :
Jun 30, 2017
Anticipated Study Completion Date :
Jul 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Melatonin and bariatric surgery

the relationship between melatonin level and analgesia requirement.

Diagnostic Test: melatonin
the relationship between melatonin level and analgesia requirement.

Outcome Measures

Primary Outcome Measures

  1. Melatonin Level [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.

Secondary Outcome Measures

  1. Morphine consumption [change from postoperative up to 24 hours]

    Morphine is analgesic agent. It will used postoperative period

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu university Malatya Turkey 044100

Sponsors and Collaborators

  • Inonu University

Investigators

  • Study Director: Türkan Toğal, Prof., Inonu University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mehmet Ali Erdoğan, Associate professor, Inonu University
ClinicalTrials.gov Identifier:
NCT03107702
Other Study ID Numbers:
  • MAE5
First Posted:
Apr 11, 2017
Last Update Posted:
Apr 11, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2017