Melatonin Level and Postoperative Analgesia Consumption i... | NCT03107702

Studies
Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.

NCT03107702

Sponsor

Inonu University

Status

Unknown status

Last Update Posted

Apr 11, 2017Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Bariatric Surgery
Melatonin
POSTOPERATIVE PAIN

Interventions

melatonin

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2017Actual

Primary Completion Date

Jun 30, 2017Estimated

Completion Date

Jul 30, 2017Estimated

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Apr 4, 2017

First Posted Date

Apr 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2017

Last Update Posted Date

Apr 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melatonin and bariatric surgery		the relationship between melatonin level and analgesia requirement.	Diagnostic Test: melatonin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
melatonin	Diagnostic Test	the relationship between melatonin level and analgesia requirement.	Melatonin and bariatric surgery

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Türkan Toğal, Prof.	Inonu University Faculty of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inonu university		Malatya	Malatya	044100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17198534	Background	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.
17180564	Background	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain