The investigation of the effects of melatonin on the rate of postoperative artrial fibrillation after coronary artery bypass grafting sutgery

Phase 3

Recruiting

• Conditions: Atrial fibrillation.; Paroxysmal atrial fibrillation; I48.0

• Registration Number: IRCT20230902059320N1
• Lead Sponsor: Karaj University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Patients aged 18 years or older, whose blood supply disorder to the heart makes them candidates for coronary artery baypass grafting surgery
Signing the consent form by the patient or the patient's qualified companion

Exclusion Criteria

People with a history of atrial fibrillation
People with a history of allergic reactions to melatonin or other ingredients in the tablet
People with the inability to swallow the oral form of melatonin in tablet form
People with unstable hemodynamics before surgery
People undergoing heart valve surgery at the same time
Emergency coronary artery bypass surgery
People with a previous history of any supraventricular arrhythmia
Use of antiarrhythmic drugs
People with kidney failure
People with chronic liver disease
Pregnant or lactating women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of people who suffer from atrial fibrillation after coronary artery bypass surgery. Timepoint: The incidence of atrial fibrillation after surgery in the first five days after CABG surgery. Method of measurement: Atrial fibrillation is diagnosed based on the absence of distinct repetitive P waves followed by irregular RR intervals lasting at least 30 seconds on a 12-lead ECG obtained from the patient.

Secondary Outcome Measures

Name	Time	Method
Examining the levels of CK-MB enzyme; troponin protein and hs-CRP. Timepoint: From one day before the operation to the first 5 days after the operation. Method of measurement: Checking the results of laboratory measurements and the information recorded in the patient's file.;Duration of atrial fibrillation after surgery. Timepoint: Daily from the day after surgery. Method of measurement: Counting the number of days a person has atrial fibrillation after coronary artery bypass surgery and recording information based on the patient's file.;Duration of hospitalization in the intensive care unit. Timepoint: Daily from the day after surgery. Method of measurement: Counting the number of days a person is hospitalized in the intensive care unit of the hospital after surgery and based on the patient's admission file.;Duration of hospitalization. Timepoint: Daily from the day after surgery. Method of measurement: Counting the number of days a person is hospitalized and based on the patient's admission file.