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: Unknown
• Conditions: POSTOPERATIVE PAIN; Bariatric Surgery; Melatonin
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 044100
    • İnonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

30 patients of American Society of Anesthesiologists (ASA) 1-2 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melatonin Level	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	Morphine is analgesic agent. It will used postoperative period	change from postoperative up to 24 hours

Collaborators and Investigators

• Sponsor: Inonu University
• 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): March 29, 2017
• Primary Completion (Anticipated): June 30, 2017
• Study Completion (Anticipated): July 30, 2017

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: MAE5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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