Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery

Ain Shams University

Status: Enrolling

Conditions: Coronary Artery Bypass Graft; Sleep Quality; Anxiety; Melatonin

Treatments: Other: Placebo; Drug: Melatonin 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06237556

FMASU MD228/2023

Details and patient eligibility

About

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.

Full description

Sleep disturbance is common among patients undergoing coronary artery bypass graft (CABG), especially during the first week of the postoperative period. Sleep disorders result in important impacts on morbidity, mortality, and quality of life.

Many factors are thought to be the cause of sleep disturbance in patients who have undergone CABG. These factors include environmental stimuli (e.g. noise and uncomfortable beds), individual characteristics (e.g. primary sleep disorder and comorbid health), nature of cardiac illnesses, and surgical complications (e.g. incisional pain, use of diuretics and resultant nocturia, dyspnea, and difficulty in finding the proper position to sleep).

Furthermore, decreased plasma melatonin concentrations have been documented during surgery and the postsurgical period in patients having undergone CABG.

Melatonin is a neurohormone originating from the amino acid, tryptophan, and is mainly secreted by the pineal gland into the blood stream and the cerebrospinal fluid. It possesses a circadian secretion pattern with a low blood concentration during the day and a high concentration at night.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Patients in the control group will receive placebo.

Treatment:

Other: Placebo

Melatonin group

Experimental group

Description:

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.

Treatment:

Drug: Melatonin 5 MG