Clinical trial

The Effect of Melatonin on Anxiety and Sleep Quality in the Peri-Operative Course of Adults Undergoing Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study

Name

FMASU MD228/2023

Description

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.

Trial arms

Trial start

2024-02-01

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Treatment

Placebo

Patients in the control group will receive placebo.

Arms:

Control group

Melatonin 5 MG

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.

Arms:

Melatonin group

Size

Primary endpoint

Quality of sleep

Five days postoperative

Eligibility criteria

Inclusion Criteria: * Age from 40-60 years. * Both sexes. * Patients undergoing standard on-pump CABG with the same technique by the same surgical team. 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 or provide informed consent

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-02-02

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication

Coronary Artery Bypass Graft