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

February 1, 2024 updated by: Ahmed ashraf abdelaziz bayoumi, Ain Shams University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Recruiting
        • Ain Shams University
        • Contact:
        • Sub-Investigator:
          • Raouf R Gadalla, MD
        • Sub-Investigator:
          • Mohamed S Shourbagy, MD
        • Sub-Investigator:
          • Rania H Abdel Hafiez, MD
        • Sub-Investigator:
          • Shaimaa M Rakhia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Patients in the control group will receive placebo.
Other: Placebo
Patients in the control group will receive placebo.
Experimental: Melatonin group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of sleep
Time Frame: Five days postoperative
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.
Five days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 24 hours postoperative

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.
24 hours postoperative
Opioid requirements
Time Frame: 24 hours postoperative
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.
24 hours postoperative
The degree of pain
Time Frame: 24 hours postoperative
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.
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD228/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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