Investigating the Effect of Melatonin Supplement on the Incidence of Delirium in Patients Undergoing Coronary Artery Bypass Graft Surgery in a Three-blind, Placebo-controlled Clinical Trial.
Determining the effect of Melatonin supplement in preventing Delirium in patients undergoing Coronary Artery Bypass Graft Surgery
Design
A controlled, Parallel-group, Triple-blind, Randomized, Phase 3 clinical trial on 146 patients. Randomized blocks were used for randomization.
Settings and conduct
Randomization based on random blocks; triple blinding strains are selected for Doctors, Researchers, Patients, etc., Patients who will undergo CABG surgery in the next 5 days at Shahid Rajaei Karaj hospital. Patients in the drug group receive Melatonin from 3 days before surgery and up to 5 days after. Control group patients also receive placebo in the same way. Patients are examined in a period of 8 days in the form of clinical examinations and questionnaires.
Participants/Inclusion and exclusion criteria
-Inclusion criteria: Patients 18 years and older who are undergoing CABG surgery; Sign the consent form
-Exclusion Criteria: History of allergic reaction to Melatonin; History of mental disorders; Severe Kidney and Liver failure; Suffering from Alzheimer's; History of Seizures; History of Delirium; Alcohol or drug addiction; Unable to swallow pills; Pregnant and Lactating women
Intervention groups
Demographic information of the patient will be recorded in all patients who enter the study. Patients in the drug group receive one 10 mg Melatonin tablet at night 1 hour before going to bed from 3 days before surgery and up to 5 days after surgery. Control group patients also receive placebo in the same way. All CAM-ICU, CAM-S, GCS, ESS, NRS questionnaires are performed by the researcher for all patients to check the Effectiveness of Melatonin in preventing Delirium.
Main outcome variables
The amount, Duration and Intensity of Delirium after surgery during the first 5 days; Duration of hospitalization of patients in ICU and hospital; Evaluation of patients' sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230820059193N1
Registration date:2023-08-30, 1402/06/08
Registration timing:prospective
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Fatemeh Sarbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 7794
Email address
fatemeh.srb2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Melatonin Supplement on the Incidence of Delirium in Patients Undergoing Coronary Artery Bypass Graft Surgery in a Three-blind, Placebo-controlled Clinical Trial.
Public title
Investigating the effect of Melatonin supplement on the incidence of Delirium After Coronary Artery Bypass Graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age, whose blood supply disorder to the heart makes them candidates for Coronary Artery Bypass Graft surgery
Patients who have no problem understanding Persian language
Signing the consent form by the patient (Consent is obtained from patients in written and verbal form)
Exclusion criteria:
People who have a history of allergic reaction to Melatonin or other ingredients in the pill
Patients who suffered cardiac and respiratory arrest
Patients who Have a history of mental disorders such as Psychosis and Mental Retardation
Patients who take Antipsychotic drugs
Patients with a history of Seizures
Patients with a history of Delirium
Patients with Alzheimer's
Patients with severe Kidney and Liver failure
Patients with Alcohol or drug addiction
Patients who need reoperation due to abnormal bleeding
Patients who are deaf
Patients who do not have the ability to speak to answer the questions in the questionnaire
Patients who are unable to swallow oral Melatonin
Patients who are candidates for emergency surgery
Pregnant and Lactating women
If older people had medicines that interfered with my research
Older people who are not able to participate in this plan for any reason
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced randomization by using random blocks. Unit of randomization: Individual patients Randomization tool: Sealed envelope containing intervention group By using random block tables, 37 blocks of 4 members according to a total of approximately 146 sample size will be chosen. Within each block there will be 2 interventions and 2 placebos. Permutations will be random and allocation to the study groups will be applied by using sealed envelope. Patients and medical providers will be unaware of the randomization scheme and study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Healthcare Personnel (Including Doctors, Nurses), Students (Principal Researcher), Participants, and the Person Evaluating the Results and the Analyst Do not Know About Receiving the Drug or Placebo. A Concealment envelope will assign patients to intervention group according to random block table. Melatonin and placebo capsule will be identical for keeping patients and medical providers blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
2th floor, Research and Technology Deputy Bldg, Research Ethics Office, 45 meter Golshahr, Shahid Safarian Alley
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.ABZUMS.REC.1402.142
Health conditions studied
1
Description of health condition studied
Incidence of Delirium After Coronary Artery Bypass Surgery
ICD-10 code
F05.8
ICD-10 code description
Postoperative delirium
Primary outcomes
1
Description
The rate of Delirium after surgery during the first 5 days after surgery
Timepoint
Investigation and recognition of confusion and monitoring of Delirium in patients of special care department is done on the day of operation and up to two days after the operation.
Method of measurement
The confusion assessment-special care (CAM-ICU) questionnaire is used to investigate and recognize confusion and monitor delusions.
Secondary outcomes
1
Description
Measuring the intensity of delirium
Timepoint
After the diagnosis of delirium until two days after the operation, its severity is checked further.
Measuring the level of alertness and the patient's responses to stimuli (Eye response - verbal response - motor response)
Timepoint
Daily from 3 days before surgery to 5 days after
Method of measurement
Glasgow Coma Scale (GCS) Scoring system
3
Description
Check the quality of sleep
Timepoint
Daily from 3 days before surgery to 5 days after
Method of measurement
Epworth Sleep scale questionnaire (ESS)
4
Description
Examining the pain intensity of patients
Timepoint
Daily from 3 days before surgery to 5 days after
Method of measurement
Numeric Rating Scale questionnaire (NRS)
5
Description
Duration of hospitalization in the intensive care unit
Timepoint
daily from the day after surgery
Method of measurement
Counting the number of days a person is hospitalized in the intensive care unit of the hospital after surgery and based on the patient's admission file
6
Description
Duration of hospitalization
Timepoint
daily from the day after surgery
Method of measurement
Counting the number of days a person is hospitalized in the intensive care unit of the hospital after surgery and based on the patient's admission file
7
Description
Measuring the duration of delirium
Timepoint
From the time people are diagnosed with delirium until the time they recover
Method of measurement
Count the number of days
Intervention groups
1
Description
Intervention group (Drug Group): 1 Oral tablet of Melatonin 10 mg manufactured by Jalinous Iran company will be taken at night from 3 days before surgery and up to 5 days after surgery.
Category
Prevention
2
Description
Control group: 1 Oral Tablet, Ineffective But Similar to the Medicine (Placebo) Manufactured by Jalinous Iran Company will be Taken at Night from 3 Days Before Surgery and up to 5 Days After Surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaie hospital
Full name of responsible person
Maryam Daei
Street address
Phase 2, block 9, entrance 1, 11th floor, NO.180, 180th unit, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396833415
Phone
+98 21 4464 7794
Email
Fatemeh.srb2000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Alborz University of Medical Sciences
Street address
Research and Technology Deputy Bldg, 45 meter Golshahr, Shahid Safarian Alley
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Maryam Daei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy building, Valiasr St., Shura Blvd., next to Bahnar Hospital
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
marydaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Maryam Daei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy building, Valiasr St., Shura Blvd., next to Bahnar Hospital
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
marydaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Maryam Daei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy building, Valiasr St., Shura Blvd., next to Bahnar Hospital
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
marydaei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It will be explained after the judging.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available