MelatoninNCT06237556
Melatonin on Anxiety and Sleep Quality in Adults Undergoing Coronary Artery Bypass Graft Surgery
A study testing Melatonin 5 MG in people with Melatonin and Anxiety, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Melatonin, Anxiety, Sleep Quality
- What is being tested?
- Melatonin 5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 40-60 years.
- Both sexes.
- Patients undergoing standard on-pump CABG with the same technique by the same surgical team.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Ahmed A Bayoumi, Master, 00201096533952, ahmed.ashraf@med.asu.edu.eg
Raouf R Gadalla, MD
About this study
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
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.
Read the 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
- Melatonin, Anxiety, Sleep Quality, Coronary Artery Bypass Graft
- Being tested
- Placebo, Melatonin 5 MG
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Patients in the control group will receive placebo.
Melatonin 5 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients in the control group will receive placebo. Receives: Other: Placebo |
| Melatonin group | Experimental | 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. Receives: Drug: Melatonin 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five days postoperative
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelatoninStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ashraf abdelaziz bayoumi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237556
- Sponsor's protocol ID
- FMASU MD228/2023
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06237556
- Acronym / sponsor ID
- FMASU MD228/2023
- Conditions
- Melatonin, Anxiety, Sleep Quality, Coronary Artery Bypass Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: PlaceboPatients in the control group will receive placebo. |
| Melatonin group | Experimental | Drug: Melatonin 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 40-60 years.
- Both sexes.
- Patients undergoing standard on-pump CABG with the same technique by the same surgical team.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPatients in the control group will receive placebo. | Other | Control group |
| Melatonin 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. | Drug | Melatonin group |
Primary outcome
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.
3 secondary outcomes
Anxiety
Time frame: 24 hours postoperative
Opioid requirements
Time frame: 24 hours postoperative
The degree of pain
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 5 MG in people with Melatonin and Anxiety, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Bayoumi, Master (00201096533952, ahmed.ashraf@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep (time frame: Five days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.