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
Determining the effect of melatonin compared to the placebo group in reducing the rate of cardiac arrhythmias during separation from the cardiopulmonary pump, the use of sleeping pills and the duration of mechanical ventilation in patients undergoing coronary artery bypass surgery.
Design
Randomized, double-blind, placebo-controlled, parallel-group clinical trial of 30 patients.
Eligible patients are assigned to the drug or placebo group through block randomization.
Settings and conduct
Location: operating room and ICU of Shahid Faqihi and Namazi hospitals in Shiraz
Patients who meet the study entry criteria are randomly assigned to the drug or placebo group. Drug 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 surgery intensive care unit. The control group receives placebo instead of melatonin while maintaining all the conditions of the intervention group
Participants/Inclusion and exclusion criteria
Age over 30 years, coronary artery transplant surgery with cardiopulmonary pump and absence of uncontrollable underlying diseases
Intervention groups
In the intervention group, patients will receive 3 mg of melatonin tablets (physiological dose) for 3 nights before the operation until the end of the day they are in the cardiac surgery intensive care unit. The control group receives placebo instead of melatonin while maintaining all the conditions of the intervention group.
Main outcome variables
Dose of intravenous sedatives, cardiac arrhythmia, duration of mechanical ventilation, length of stay in ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250206064666N1
Registration date:2025-02-24, 1403/12/06
Registration timing:prospective
Last update:2025-02-24, 1403/12/06
Update count:0
Registration date
2025-02-24, 1403/12/06
Registrant information
Name
Bahare Firouzbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
bfirouzbakht@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-10-23, 1404/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the effect of melatonin in patients undergoing coronary artery bypass surgery
Purpose
Prevention
Inclusion/Exclusion 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:
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
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the samples will be based on the block randomization method. Blocks of four are generated using the website dedicated to this calculation (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Each of the patients entering the study will be assigned a code, and the type of group that should take medicine or placebo will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the preparation of melatonin tablets (manufactured by Aria Daru Company, Iran) and placebo (completely similar to the drug in terms of size and color, manufactured by the Faculty of Pharmacy of Shiraz University of Medical Sciences), the drug or placebo with a specified number for one patient is placed in a similar package by the project manager, and the specific code of each patient is inserted on the package. The patient, the data collector and the interventionist do not know about the distribution of patients in the two drug and placebo groups until the completion of the study and the disclosure of its codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Building No. 3, Shiraz Faculty of Medicine, Imam Hossein Square, Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2025-02-05, 1403/11/17
Ethics committee reference number
IR.SUMS.REC.1403.494
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Dose of intravenous hypnotic drug
Timepoint
The first day after surgery
Method of measurement
Patient file
2
Description
Cardiac arrhythmia
Timepoint
During weaning from the cardiopulmonary pump
Method of measurement
Observation
3
Description
Duration of using mechanical ventilation
Timepoint
After surgery
Method of measurement
Observation
Secondary outcomes
1
Description
Mortality
Timepoint
Until discharge from ICU
Method of measurement
counting
2
Description
Length of stay in ICU
Timepoint
At the time of discharge from the ICU
Method of measurement
Counting
Intervention groups
1
Description
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 surgery intensive care unit.
Category
Treatment - Other
2
Description
Control group: The control group receives placebo instead of melatonin while maintaining all the conditions of the intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Bahare Firouzbakht
Street address
Namazi Blvd
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Bahare Firouzbakht
Street address
Karim Khan Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
FaghihiHsp@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Karim Khan Zand Boulevard, Research and Technology Vice-Chancellor, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahare Firouzbakht
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Cardiovascular Perfusion
Street address
School of Nursing and Midwifery, Karim Khan Zand Blvd., Nemazee Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
bfirouzbakht@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahare Firouzbakht
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
School of Nursing and Midwifery, Karim Khan Zand Blvd., Nemazee Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
bfirouzbakht@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahare Firouzbakht
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
School of Nursing and Midwifery, Karim Khan Zand Blvd., Nemazee Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
bfirouzbakht@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD