Clinical trial NCT06237556: Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melatonin
Anxiety
Sleep Quality
Coronary Artery Bypass Graft
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of sleep
timeFrame: Five days postoperative
Secondary outcomes:
measure: Anxiety
timeFrame: 24 hours postoperative
measure: Opioid requirements
timeFrame: 24 hours postoperative
measure: The degree of pain
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: