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

NCT06237556 | Recruiting

• 1 other identifier: FMASU MD228/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melatonin; Anxiety; Sleep Quality; Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

• Quality of sleep

  Sleep quality will be evaluated using the Groningen Sleep Quality Score (GSQS), The GSQS consists of 15 questions about the previous night's sleep, answered with Yes or No.

  Five days postoperative

Secondary Outcomes (3)

• Anxiety

  24 hours postoperative

• Opioid requirements

  24 hours postoperative

• The degree of pain

  24 hours postoperative

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients in the control group will receive placebo.

Other: Placebo

Melatonin group

EXPERIMENTAL

Three days before the operation patients will receive 5 mg of melatonin (Melatonin, Nature Made, Canada, and USA) one hour before assigned sleep time until the time of discharge from hospital.

Drug: Melatonin 5 MG

Interventions

Placebo OTHER

Patients in the control group will receive placebo.

Control group

Melatonin 5 MG DRUG

Three days before the operation patients will receive 5 mg of melatonin (Melatonin, Nature Made, Canada, and USA) one hour before assigned sleep time until the time of discharge from hospital.

Melatonin group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 or provide informed consent

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Ahmed A Bayoumi, Master

CONTACT

00201096533952; ahmed.ashraf@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt.

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)