Endogenous Melatonin Level and Pre- Postoperative Anxiety in Bariatric Surgery Patients.

Sponsor
Inonu University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03109054
Collaborator
(none)
50
1
3
16.5

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.

Different level anxiety that can define as fear or worry can be seen in 60%-80% of patients scheduled surgery. Anxiety levels; may vary on age, gender, type of operation, previous experience of anesthesia and surgery and way of hospitalization. Preoperative anxiety affects negatively the surgery, the anesthesia and postoperative recovery.

Melatonin is a hormone secreted from the pineal gland. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative, analgesic and has a preventive effect of delirium in intensive care. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. It has been demonstrated that oral exogen administration of melatonin was effective on preoperative anxiety.

The aim of this study was to determine the relationship between endogenous melatonin levels and anxiety levels in patients with bariatric surgery.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: State-Trait Anxiety Inventory Test

Detailed Description

Bariatric surgical procedures, including gastric bypass, vertical sleeve gastrectomy, and biliopancreatic diversion, are the most effective and durable treatments for obesity. Bariatric surgery provides long-term benefit for patients with diabetes, fatty liver disease, and other metabolic disorders, through both weight loss-dependent and -independent mechanisms.

Bariatric surgery is 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.

Different level anxiety that can define as fear or worry can be seen in 60%-80% of patients scheduled surgery. Anxiety levels; may vary on age, gender, type of operation, previous experience of anesthesia and surgery and way of hospitalization. Preoperative anxiety affects negatively the surgery, the anesthesia and postoperative recovery. It may cause the pathophysiological response as hypertension and arrhythmia even refusal the surgery is planned. Also the anesthetic requirements and the risk "awareness" during the operation may increase. Patients with high level anxiety have more postoperative pain symptoms too. Therefore determination of the causes and prevention of anxiety is important.

Melatonin is a hormone secreted from the pineal gland, also known as the pineal gland. It's production is stimulated by darkness, independent of sleep, and is inhibited by exposure to light and proved endocrine rhythms. It shows a daily biorhythm. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin level can be measured in the blood and in urine collected for 24 hours. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative, analgesic and has a preventive effect of delirium in intensive care. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. It has been demonstrated that oral exogen administration of melatonin was effective on preoperative anxiety.

The aim of this study was to determine the relationship between endogenous melatonin levels and anxiety levels in patients with bariatric surgery.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Role of Endogenous Melatonin Level in Preoperative and Postoperative Anxiety in Bariatric Surgery Patients
Actual Study Start Date :
Mar 15, 2017
Anticipated Primary Completion Date :
May 15, 2017
Anticipated Study Completion Date :
Jun 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Low Anxiety Level

The patients had low anxiety levels. Anxiety levels will determine with S-Anxiety TX-1 (State-Trait Anxiety Inventory Test:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3879951/)

Diagnostic Test: State-Trait Anxiety Inventory Test
All patients will take a State-Trait Anxiety Inventory Test. After the test patients will enroll low or high anxiety level.
Other Names:
  • STAI FORM TX-1
  • High Anxiety Level

    The patients had high anxiety levels. Anxiety levels will determine with S-Anxiety (State-Trait Anxiety Inventory Test: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3879951/)

    Diagnostic Test: State-Trait Anxiety Inventory Test
    All patients will take a State-Trait Anxiety Inventory Test. After the test patients will enroll low or high anxiety level.
    Other Names:
  • STAI FORM TX-1
  • Outcome Measures

    Primary Outcome Measures

    1. change in melatonin levels [preoperative and 24. hour after postoperative]

      Melatonin is a hormone secreted from the pineal gland. It shows a daily biorhythm. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin level can be measured in the blood and in urine collected for 24 hours.

    Secondary Outcome Measures

    1. S-Anxiety (State-Trait Anxiety Inventory Test [preoperative and 24. hour after postoperative]

      Anxiety levels; may vary on age, gender, type of operation, previous experience of anesthesia and surgery and way of hospitalization.

    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

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mehmet Ali Erdoğan, Associate Professor, M.D., Inonu University
    ClinicalTrials.gov Identifier:
    NCT03109054
    Other Study ID Numbers:
    • MAE4
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Apr 12, 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
    Keywords provided by Mehmet Ali Erdoğan, Associate Professor, M.D., Inonu University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2017