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

Overview

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.

Full Title of Study: “Role of Endogenous Melatonin Level in Preoperative and Postoperative Anxiety in Bariatric Surgery Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 15, 2017

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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/)
  • 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/)

Clinical Trial Outcome Measures

Primary Measures

  • change in melatonin levels
    • Time Frame: 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 Measures

  • S-Anxiety (State-Trait Anxiety Inventory Test
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inonu University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mehmet Ali Erdo─čan, Associate Professor, M.D. – Inonu University

Citations Reporting on Results

Cardoso L, Rodrigues D, Gomes L, Carrilho F. Short- and long-term mortality after bariatric surgery: A systematic review and meta-analysis. Diabetes Obes Metab. 2017 Sep;19(9):1223-1232. doi: 10.1111/dom.12922. Epub 2017 May 31. Review.

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

Edwards-Hampton SA, Madan A, Wedin S, Borckardt JJ, Crowley N, Byrne KT. A closer look at the nature of anxiety in weight loss surgery candidates. Int J Psychiatry Med. 2014;47(2):105-13. doi: 10.2190/PM.47.2.b.

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