Clinical Trials Directory

Trials / Unknown

UnknownNCT06237556

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

The Effect of Melatonin on Anxiety and Sleep Quality in the Peri-Operative Course of Adults Undergoing Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
40 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERPlaceboPatients in the control group will receive placebo.
DRUGMelatonin 5 MGThree 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.

Timeline

Start date
2024-02-01
Primary completion
2024-12-01
Completion
2024-12-01
First posted
2024-02-01
Last updated
2024-02-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06237556. Inclusion in this directory is not an endorsement.