Comparison of the effect of Dexmedetomidine and Melatonin on delirium in patients after coronary artery bypass graft surgery
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 58 patients who will be undergoing Coronary artery bypass grafting will be enrolled. Eligible patients will be randomly allocated into two equal A and B groups by block randomization.
Settings and conduct
Patients who are candidates for Coronary artery bypass grafting who visit Abu Ali Sina Organ Transplantation Hospital in Shiraz during the study will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using the random block method. This study will be conducted in a double-blind manner, so that the patients and the examining physician and the outcome assessor will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA grade II or III (American Society of Anesthesiology classification), Patients between 18 and 65 years old and Candidate for coronary artery bypass surgery.
Exclusion criteria: Allergy to the drugs used in the study, Positive history of psychological problems and Positive history of taking sleeping pills
Intervention groups
The first group receiving melatonin: The patients of this group receive 6 mg melatonin tablets one night before the operation, and normal saline is infused as a placebo during the operation.
The second group receiving dexmedetomidine: in the opposite group, they received starch tablets as a placebo from the night before the operation and during the operation Dexmedetomidine 1 mcg/kg as a bolus within ten minutes And 0.4 mcg/kg per minute is infused.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120214009011N3
Registration date:2024-05-28, 1403/03/08
Registration timing:registered_while_recruiting
Last update:2024-05-28, 1403/03/08
Update count:0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
Reza Jouybar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7636
Email address
joybarr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-01, 1403/02/12
Expected recruitment end date
2024-12-01, 1403/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dexmedetomidine and Melatonin on delirium in patients after coronary artery bypass graft surgery
Public title
Comparison of the effect of dexmedetomidine and melatonin on unconsciousness in patients after coronary artery bypass surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade II or III (American Society of Anesthesiology classification)
Patients between 18 and 65 years old
Candidate for coronary artery bypass surgery
Exclusion criteria:
Allergy to the drugs used in the study
Positive history of psychological problems
Positive history of taking sleeping pills
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 4, 6 and 8 will be made for patients of two groups A & B. patients will be allocated randomly and equally into two groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
The personnel present in each room after the end of surgery and transferring the patient to the intensive care unit and handing over the patient to the intensive care unit personnel will not give any information to the staff and only the ICU supervisor is aware of the drugs and is suspicious of the order of the patient, the anesthesia resident and the nurse. The intensive care unit and the data analyst are blinded to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School.
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.SUMS.MED.REC.1401.218
Health conditions studied
1
Description of health condition studied
Coronary artery bypass grafting
ICD-10 code
I25.81
ICD-10 code description
Atherosclerosis of other coronary vessels without angina pectoris
Primary outcomes
1
Description
Delirium after surgery
Timepoint
at 0, 2, 4, 8, 12, 18, and 24 hours after surgery in the ICU.
Method of measurement
Standard Test of Confusion Assessment Method for ICU (CAM-ICU)
Secondary outcomes
empty
Intervention groups
1
Description
The first group receiving melatonin: The patients of this group receive 6 mg melatonin tablets one night before the operation, and normal saline is infused as a placebo during the operation.
Category
Treatment - Drugs
2
Description
The second group receiving dexmedetomidine: in the opposite group, they received starch tablets as a placebo from the night before the operation and during the operation Dexmedetomidine 1 mcg/kg as a bolus within ten minutesAnd 0.4 mcg/kg per minute is infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Organ Transplantation Hospital
Full name of responsible person
Golzar Sharifian
Street address
Sadra, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71994-67985
Phone
+98 71 3344 0000
Email
hospitalabualisina@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hashem Hashempour
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?