Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06237556
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: