To assess the effect of gabapentin versus placebo on delirium after surgery in patients with coronary artery bypass graft
Design
This is a double-blind randomized clinical trial, in which 68 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are candidate for coronary artery bypass graft surgery referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 75 years,
Candidate for coronary artery bypass graft,
Exclusion criteria:
Sensitivity to gabapentin medication
Intervention groups
Intervention group:
Two gabapentin capsules 400 mg (manufactured by Oxir Pharmaceutical Co.) 2 hours before surgery and then on gabapentin capsule 400 mg every 12 hours for 3 das
Control group:
Two placebo capsules (containing starch) 2 hours before surgery and then on placebo capsule 400 mg every 12 hours for 3 das
Main outcome variables
Primary outcome:
delirium
Secondary outcome:
Probable side effect including drowsiness, nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N393
Registration date:2021-05-03, 1400/02/13
Registration timing:prospective
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of gabapentin versus placebo on delirium after surgery in patients with coronary artery bypass graft: a double-blind randomized clinical trial
Public title
Effect of gabapentin versus placebo on delirium after surgery in patients with coronary artery bypass graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 75 years,
Candidate for coronary artery bypass graft,
Exclusion criteria:
Sensitivity to gabapentin medication
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.UMSHA.REC.1398. 687
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Measuring delirium
Timepoint
Before surgery and 3 days after that
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Probable side effect including drowsiness, nausea and vomiting
Timepoint
up to 3 days after surgery
Method of measurement
By history taking
Intervention groups
1
Description
Intervention group: Two gabapentin capsules 400 mg (manufactured by Oxir Pharmaceutical Co.) 2 hours before surgery and then on gabapentin capsule 400 mg every 12 hours for 3 das
Category
Treatment - Drugs
2
Description
Control group: Two placebo capsules (containing starch) 2 hours before surgery and then on placebo capsule 400 mg every 12 hours for 3 das
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Dr Parya Sayarfar
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
saiyarfar.paria@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Parya Sayarfar
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
saiyarfar.paria@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Davoodi
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mdavoudi10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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