Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.

POSTOPERATIVE PAIN Clinical Trial

Official title:

Relationship Between Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03107702
• Other study ID #: MAE5
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 29, 2017
• Last updated: April 4, 2017
• Start date: March 29, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: April 2017
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: July 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Melatonin
• Pain, Postoperative
• POSTOPERATIVE PAIN

Intervention

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

Locations

Country	Name	City	State
Turkey	Inonu university	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gögenur 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. — View Citation

Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914. — View Citation

Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morphine consumption	Morphine is analgesic agent. It will used postoperative period	change from postoperative up to 24 hours