Effect of gabapentin on prevention of delirium in patients undergoing coronary artery bypass graft surgery
Design
a randomized triple blind placebo control clinical trial
Settings and conduct
58 patients undergoing coronary artery bypass graft surgery at Yazd Afshar Hospital were randomly assigned to one drug before surgery and the first and second days after surgery. Patient, researcher, physician, nurse, analyzer did not know the contents of the capsule medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients who were candidates for coronary artery bypass surgery were included in the study.
Exclusion criteria:
1)History of taking anticonvulsants
2)History of Gabapentin use in the last two weeks
3)Proven history of psychiatric problem (psychosis)
4)Emergency Surgery
5)ICU admission before surgery
6)Delirium before surgery
7)Previous cardiac surgery history
Intervention groups
Patients undergoing coronary artery bypass graft surgery receive one capsule of code A or B one hour prior to surgery based on the randomized number table. They receive one capsule on the first and second day after surgery. Trained nurses will be evaluated according to the CAM-ICU criteria at 6 pm and 12 pm and recorded in the appropriate form.If the patient showed signs of delirium out of the above hours, the extra form for the patient became full and replaced one of the normal forms of the day.
Main outcome variables
Prevention of delirium after surgery and reduction of hospital stay and mortality and morbidity after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200306046706N1
Registration date:2020-04-16, 1399/01/28
Registration timing:retrospective
Last update:2020-04-16, 1399/01/28
Update count:0
Registration date
2020-04-16, 1399/01/28
Registrant information
Name
Elham Farzannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 7273
Email address
elhamfarzannejad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2020-01-21, 1398/11/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
The effect of Gabapentin on prevention of delirium in patients undergoing coronary artery bypass graft surgery
Public title
Effect of Gabapentin on prevention of Delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing Coronary Artery Bypass Graft Surgery
Exclusion criteria:
History of taking anticonvulsants,
History of Gabapentin drugs consumption in the last two weeks
History of proven psychological problems
Emergency surgery
ICU Admision before surgeon
Delirium before surgery
History of previous cardiac surgery
Age
From 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Using a Random Number Table,Individuals in two groups A and B were included in the study
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant: After giving informed consent, they entered the intervention groups.
Investigator:Not knowing which group A and B are medication and placebo .
Physician and nurse: Not knowing which group A and B are medication and placebo .
Outcome assessor:Not knowing which group A and B are medication and placebo .
Data analyzer:Not knowing which group A and B are medication and placebo .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Second Kui, Shahid Ashtarzadeh Alley, Maskan Street, Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915664167
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.105
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease, Delirium, Open Coronary Heart Surgery
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Permitted delirium according to the CAM-IC criteria
Timepoint
Examine delirium twice daily, days 1, 2, 3
Method of measurement
Confusion Assessment Method-ICU
Secondary outcomes
1
Description
Postoperative mortality
Timepoint
Death occurring from 36 hours to one month after surgery
Method of measurement
Phone Follow up
Intervention groups
1
Description
Intervention group: Gabapentin 400 mg capsule, daily, for three days, with sufficient water in the morning, prepared by the Pharmacology Group.
Category
Prevention
2
Description
Control group: Multivitamin Capsule, daily, for three days, in the morning with sufficient amount of water, prepared by Pharmacology Group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Elham Farzannejad
Street address
Second Kui,Shahid Ashtarzadeh Alley, Maskan Street, Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915664167
Phone
+98 35 3623 7273
Email
elhamfarzannejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Second Kui, Shahid Ashtarzade Alley, Maskan Street, Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915664167
Phone
+98 35 3623 7273
Email
elhamfarzannejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elham Farzannejad
Position
Assistant
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Second Kui, Shahid Ashtarzade Alley, Maskan Street, Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915664167
Phone
+98 35 3623 7273
Email
elhamfarzannejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elham Farzannejad
Position
Assistant
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Second Kui, Shahid Ashtarzade Alley, Maskan Street, Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915664167
Phone
+98 35 3623 7273
Email
elhamfarzannejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elham Farzannejad
Position
Assistant
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Second Kui, Shahid Ashtarzade Alley, Maskan Street, Kashani Ave
City
Yazd
Province
Yazd
Postal code
8915664167
Phone
+98 35 3623 7273
Email
elhamfarzannejad@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