Skip to content

Investigating the effect of Melatonin supplement on the incidence of Delirium After Coronary Artery Bypass Graft surgery

Investigating the Effect of Melatonin Supplement on the Incidence of Delirium in Patients Undergoing Coronary Artery Bypass Graft Surgery in a Three-blind, Placebo-controlled Clinical Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230820059193N1
Enrollment
146
Registered
2023-08-30
Start date
2023-09-23
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Incidence of Delirium After Coronary Artery Bypass Surgery. Postoperative delirium

Interventions

Intervention 1: Intervention group (Drug Group): 1 Oral tablet of Melatonin 10 mg manufactured by Jalinous Iran company will be taken at night from 3 days before surgery and up to 5 days after surgery

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age, whose blood supply disorder to the heart makes them candidates for Coronary Artery Bypass Graft surgery Patients who have no problem understanding Persian language Signing the consent form by the patient (Consent is obtained from patients in written and verbal form)

Exclusion criteria

Exclusion criteria: People who have a history of allergic reaction to Melatonin or other ingredients in the pill Patients who suffered cardiac and respiratory arrest Patients who Have a history of mental disorders such as Psychosis and Mental Retardation Patients who take Antipsychotic drugs Patients with a history of Seizures Patients with a history of Delirium Patients with Alzheimer's Patients with severe Kidney and Liver failure Patients with Alcohol or drug addiction Patients who need reoperation due to abnormal bleeding Patients who are deaf Patients who do not have the ability to speak to answer the questions in the questionnaire Patients who are unable to swallow oral Melatonin Patients who are candidates for emergency surgery Pregnant and Lactating women If older people had medicines that interfered with my research Older people who are not able to participate in this plan for any reason

Design outcomes

Primary

MeasureTime frame
The rate of Delirium after surgery during the first 5 days after surgery. Timepoint: Investigation and recognition of confusion and monitoring of Delirium in patients of special care department is done on the day of operation and up to two days after the operation. Method of measurement: The confusion assessment-special care (CAM-ICU) questionnaire is used to investigate and recognize confusion and monitor delusions.

Secondary

MeasureTime frame
Measuring the intensity of delirium. Timepoint: After the diagnosis of delirium until two days after the operation, its severity is checked further. Method of measurement: Confusion Assessment Method-severity (CAM-S) questionnaire.;Measuring the level of alertness and the patient's responses to stimuli (Eye response - verbal response - motor response). Timepoint: Daily from 3 days before surgery to 5 days after. Method of measurement: Glasgow Coma Scale (GCS) Scoring system.;Check the quality of sleep. Timepoint: Daily from 3 days before surgery to 5 days after. Method of measurement: Epworth Sleep scale questionnaire (ESS).;Examining the pain intensity of patients. Timepoint: Daily from 3 days before surgery to 5 days after. Method of measurement: Numeric Rating Scale questionnaire (NRS).;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 in the intensive care unit of the hospital after surgery and based on the patient's admission file.;Measuring the duration of delirium. Timepoint: From the time people are diagnosed with delirium until the time they recover. Method of measurement: Count the number of days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Daei

Karaj University of Medical Sciences

marydaei@yahoo.com+98 26 3256 7175

Outcome results

None listed

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