Determining the Effect of Melatonin on Delirium After Cardiac Surgery
Design
Two arm parallel groups randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
After obtaining permission from the Ethics Committee, the patients will be randomized to two groups of 30 (case and control). In the case of malathion, the control group will be given a placebo. Delirium incidence variables (based on CAM-ICU) and severity It (according to MDAS) is reviewed and recorded. Also, information on the duration of the operation, the duration of the cardiopulmonary bypass pump, the length of time required for mechanical ventilation after surgery, and the duration of admission to the ICU are recorded and compared in the two groups.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1-age 30 and above
2. Candidate for elective or semi-elective coronary artery bypass graft surgery (On-Pump CABG)
3. Risk of Anesthesia 1-3
4-Insensitivity to melatonin
exclusion criteria:
1-No informed consent
2. Emergency surgery
3. Presence of melatonin inhibition, allergy to the drug or its compounds.
4. Chronic or recent use of melatonin or hypnotic drugs
5. Treated with barbiturates or anti psychotics
6. History of liver or kidney disease or chronic pulmonary disease
Intervention groups
In the case group, a melatonin(Webber Naturals® Canada) dose of 3 mg, the night before the operation (8 nights) and the morning of the day (6 am) and night (8 nights) until 48 hours after the operation
In the control group, the placebo (pharmaceutical gypsum) was prescribed the same day before the surgery (8 nights) and the morning of the day (6 am) and every night (8 nights) until 48 hours after the operation.
Main outcome variables
Delirium incidence; Severity of Delirium; Mechanical ventilation time; Intensive care unit staying
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040979N3
Registration date:2019-07-30, 1398/05/08
Registration timing:registered_while_recruiting
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
MARYAM ZAMANKHANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 4760
Email address
zamankhani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Melatonin on Delirium after Cardiac Surgery
Public title
Delirium after Cardiac Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 and older
Candidate for elective coronary artery bypass graft under cardiopulmonary pumps
Anesthesia class 1-3
Insensitivity to melatonin
Exclusion criteria:
Lack of informed consent
Emergency Surgery
Chronic or recent use of melatonin or hypnotic drugs
Treated with barbiturates or anti psychotics
History of liver or kidney disease or chronic pulmonary disease
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Individuals are randomly divided into two groups based on randomized block randomization method. Randomized blocks are used for this purpose. A random sample based on this method from Sealedenvelope.com has been extracted.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the intervention group, the melatonin tablet and in the control group a tablet will be given the same shape form. Given the fact that the two tablets do not differ significantly in color and shape, thus it can be said that the patient, surgeon and researcher did not have any information on how the subjects were placed in the group .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences., Research Deputy.,Blvd. Golestan .Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.AJUMS.REC.1398.199
Health conditions studied
1
Description of health condition studied
Patients candidate for coronary artery bypass graft surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Delirium incidence
Timepoint
From Start of study for 2 days after performing the CABG
Method of measurement
Based on CAM-ICU
2
Description
Severity of delirium
Timepoint
From Start of study for 2 days after performing the CABG
Method of measurement
Based on MDAS
3
Description
Mechanical ventilation duration
Timepoint
6,8,10,12 ,24 hours after surgery
Method of measurement
Hour
4
Description
Duration of ICU staying
Timepoint
2,3,4 days after surgery
Method of measurement
Day
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in group 1 melatonin tablet (Webber Naturals® Canada) (3 mg), the night before surgery (8 nights) and the morning of surgery (6 am) and the night of surgery(8 nights) up to 48 hours after the operation
Category
Prevention
2
Description
Control group: In the placebo group, the same figure tablet was used the night before surgery (8 nights) and the morning of surgery (6 am) and the night of surgery(8 nights) every night (8 nights) until 48 hours after the operation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Street address
Golestan hospital.Blvd golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3391 9315
Email
f_javaherforoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohamad Badavi
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7550
Email
Badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.1, West Maroon, East13, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155979939
Phone
+98 61 3391 9315
Email
f_javaherforoosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.1, West Maroon, East13, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3391 9315
Email
f_javaherforoosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.1, West Maroon, East13, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155979939
Phone
+98 61 3391 9315
Email
f_javaherforoosh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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