An interventional study of Placebo and Melatonin 5 MG in Melatonin, Anxiety and Sleep Quality, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the control group will receive placebo.
Other: Placebo
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.
Drug: Melatonin 5 MG
Patients in the control group will receive placebo.
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.
Quality of sleep
Sleep quality will be evaluated using the Groningen Sleep Quality Score (GSQS), The GSQS consists of 15 questions about the previous night's sleep, answered with Yes or No.
Time frame: Five days postoperative
Anxiety
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire employed by clinicians to rate the severity of anxiety. This scale includes 14 items. Each consists of a number of symptoms, and the symptoms are graded on a scale of zero to four. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time frame: 24 hours postoperative
Opioid requirements
Postoperative analgesia in the ICU was carried out for both groups. All patients received IV fentanyl infusion (0.5ugm/kg/hr) with 15ug bouls if sudden rise in Heart rate or mean arterial blood pressure \> 20% of base line to be stopped before extubation, after extubation Paracetamol 1gm was given every 8 hours for all patients, diclofenac 75mg /12hr.
Time frame: 24 hours postoperative
The degree of pain
The degree of pain will be assessed using numerical rating scale (NRS) requires for sternal pain, the patient to rate their pain on a defined scale from 0-10 where 0 is no pain and 10 is the worst pain) measured at time intervals: 30 minutes, 6hours, 12hours, and 24h after extubation. If NRS \> 4 rescue analgesia will be given in form of IV morphine0.05mg /kg.
Time frame: 24 hours postoperative
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University