Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery

Last updated: February 1, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

Melatonin 5 MG

Placebo

Clinical Study ID

NCT06237556
FMASU MD228/2023
  • Ages 40-60
  • All Genders

Study Summary

The objective of this study is to evaluate the effect of melatonin on post operative sleeping quality, anxiety, and post-operative opioid requirements in adults post coronary artery bypass graft (CABG) surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 40-60 years.
  • Both sexes.
  • Patients undergoing standard on-pump CABG with the same technique by the same surgicalteam.

Exclusion

Exclusion Criteria:

  • Refusal of procedure or participation in the study by patients.
  • Patients with known history of allergy to one of study drugs
  • Patients taking psychiatric medications, CNS depressants, and hypnotic drugs.
  • Patients with neurological disorders stroke, intracranial hemorrhage and surgery.
  • Patients with a history of suffering from any sleep disorder.
  • Severe circulatory or respiratory disease.
  • Patients with obstructive sleep apnea.
  • Cognitive or psychiatric illness that leads to inability to cooperate, speak orprovide informed consent

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Melatonin 5 MG
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
December 01, 2024

Study Description

Sleep disturbance is common among patients undergoing coronary artery bypass graft (CABG), especially during the first week of the postoperative period. Sleep disorders result in important impacts on morbidity, mortality, and quality of life.

Many factors are thought to be the cause of sleep disturbance in patients who have undergone CABG. These factors include environmental stimuli (e.g. noise and uncomfortable beds), individual characteristics (e.g. primary sleep disorder and comorbid health), nature of cardiac illnesses, and surgical complications (e.g. incisional pain, use of diuretics and resultant nocturia, dyspnea, and difficulty in finding the proper position to sleep).

Furthermore, decreased plasma melatonin concentrations have been documented during surgery and the postsurgical period in patients having undergone CABG.

Melatonin is a neurohormone originating from the amino acid, tryptophan, and is mainly secreted by the pineal gland into the blood stream and the cerebrospinal fluid. It possesses a circadian secretion pattern with a low blood concentration during the day and a high concentration at night.

Connect with a study center

  • Ain Shams University

    Cairo, 11591
    Egypt

    Active - Recruiting

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