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Investigating the effect of melatonin in patients undergoing coronary artery bypass surgery

Investigating the effect of melatonin in reducing the rate of cardiac arrhythmias during weaning from the cardiopulmonary bypass, reducing the need for sedative agents, and reducing duration of mechanical ventilation in patients undergoing coronary artery bypass graft surgery in Namazi and Shahid Faghihi Hospitals of Shiraz 2025 - 2026: a randomized, double-blinded, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250206064666N1
Enrollment
30
Registered
2025-02-24
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease. Atherosclerotic heart disease of native coronary artery

Interventions

Intervention 1: Intervention group: In the intervention group, patients will receive 3 mg of melatonin tablets for 3 nights before the operation until the end of the day when they are in the cardiac s

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective coronary artery bypass surgery using on-pump (CABG) in Shahid Faqihi and Namazi hospitals in Shiraz Age above 30 years ASA: 1-3 GCS:15

Exclusion criteria

Exclusion criteria: Age less than 30 years Emergency surgery Valve surgery at the same time as coronary artery bypass surgery Off-pump surgery More than 4 coronary artery grafts Previous history of any cardiac arrhythmia Having a pacemaker Local or systemic infection Heart failure with an ejection fraction of less than 30% Uncontrolled blood pressure and diabetes History of seizures History of recent or chronic use of psychiatric drugs, sleeping pills, alcohol and melatonin Severe liver, kidney and lung diseases inability to speak malignancy Pregnancy and breastfeeding Allergy to melatonin

Design outcomes

Primary

MeasureTime frame
Dose of intravenous hypnotic drug. Timepoint: The first day after surgery. Method of measurement: Patient file.;Cardiac arrhythmia. Timepoint: During weaning from the cardiopulmonary pump. Method of measurement: Observation.;Duration of using mechanical ventilation. Timepoint: After surgery. Method of measurement: Observation.

Secondary

MeasureTime frame
Mortality. Timepoint: Until discharge from ICU. Method of measurement: counting.;Length of stay in ICU. Timepoint: At the time of discharge from the ICU. Method of measurement: Counting.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahare Firouzbakht

Shiraz University of Medical Sciences

bfirouzbakht@sums.ac.ir+98 71 3647 4254

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026