Investigation of the effect of modafinil on respiratory and cerebral consequences after coronary artery bypass graft surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 74 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
The study is being performed at the Shahid Chamran Heart Medical Center in Isfahan on patients who are candidates for coronary artery bypass graft surgery, during which surgery is started after induction of anesthesia. Arterial blood samples are taken from all patients, and this is done every hour until the end of the operation. After the patient is wening from the cardiopulmonary bypass pump, a simple, individual randomized delivery of modafinil at a dose of 200 mg is given to the patient by the intervention group and the placebo is given to the patient by the control group orally with a nasogastric tube. After the surgery, the patients are transferred to the intensive care unit and arterial blood samples are taken from the patients, and this is done every three hours until the end of the hospitalization period. Once patients are awake and the level of consciousness is checked by the Richmond-Agitation Scale, it is done every hour until they reach full consciousness.
Participants/Inclusion and exclusion criteria
Patients with coronary artery bypass graft surgery with a cardiac ejection fraction of more than 40% and without liver and kidney dysfunction and without irregular primary rhythm and cardiomegaly.
Intervention groups
After weaning of the patient from the cardiopulmonary bypass pump, the modafinil is given at a dose of 200 mg to the patient of the intervention group and the placebo is given to the control group orally with a nasogastric tube.
Main outcome variables
Check the duration of hospital stay,
Results and quality of life
And check readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200611047728N1
Registration date:2020-08-06, 1399/05/16
Registration timing:registered_while_recruiting
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Mohammad Kazem Rezaei Hosein Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 1400
Email address
drmkrezaei_62@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of modafinil on respiratory and cerebral consequences after coronary artery bypass graft surgery
Public title
Investigation of the effect of modafinil in coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with coronary artery bypass graft surgery
patients with a cardiac ejection fraction of more than 40%
Exclusion criteria:
Patients with hepatic function failure
Patients with renal function failure
Patients with irregular cardiac primary rhythms
Patients with cardiomegaly
patients who have drug addiction
patients who have alcoholism
patients who are using psychiatric drugs
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple randomization, randomization unit: individual, randomization tool: randomized number table. The couple numbers will be in the intervention group and the odd numbers will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The control drug is similar in appearance to the modafinil drug and is given to the patient by a person who has no role in the test, and then the information is collected by the same person
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezarjerib St. Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.MUI.MED.REC.1399.265
Health conditions studied
1
Description of health condition studied
respiratory and cerebral outcomes
ICD-10 code
J96.92, F1
ICD-10 code description
Respiratory failure, unspecified with hypercapnia, Sedative, hypnotic or anxiolytic use, unspecified with sedative, hypnotic or anxiolytic-induced sleep disorder
Primary outcomes
1
Description
The time to reach full consciousness
Timepoint
Every hour until you reach full consciousness
Method of measurement
Richmond-Agitation Scale
2
Description
Duration of mechanical ventilation in the intensive care unit
Timepoint
Every hour until you reach full consciousness
Method of measurement
In minutes using time meter
3
Description
Length of stay in Intensive Care Unit
Timepoint
Every day until discharge from Intensive Care Unit
Method of measurement
By day using Count days
4
Description
Carbon dioxide arterial pressure
Timepoint
Every one hour
Method of measurement
Arterial blood samples based on mercury mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: After induction of anesthesia and endotracheal intubation, surgery will begin and after isolation of the patient from cardiopulmonary pump, modafinil (the drug is produced by Sobhan Daru Company) will be given to the patient orally with nasogastric tube by a person who has no role in the test. On the second morning of hospitalization, 200 mg modafinil will be given to patients in the intervention group orally by a person who has no role in the test.
Category
Treatment - Drugs
2
Description
Control group: After induction of anesthesia and endotracheal intubation, surgery will begin and after isolation from cardiopulmonary pump, the patient will be given placebo randomly and individually to the control group orally with nasogastric tube by a person who has no role in the test. On the second morning of hospitalization, the second dose of placebo will be given to the patient in the control group orally by a person who has no role in the test.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran University, Health and Research Center
Full name of responsible person
Dr. Mojtaba Mansouri
Street address
Shahid Chamran Hospital, Bozorgmehr Bridge, 3rd moshtagh Street
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1400
Fax
+98 31 3261 1405
Email
Drmkrezaei_62@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences and health services, Hezar jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
Drmkrezaei_62@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Mansouri
Position
Associate Professor, Department of Anesthesiology, Isfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Hospital, Bozorgmehr Bridge, third moshtagh Street
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1400
Fax
+98 31 3261 1405
Email
Drmkrezaei_62@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Mansouri
Position
Associate Professor, Department of Anesthesiology, Isfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Heart Hospital, Bozorgmehr Bridge, third moshtagh Street
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1400
Fax
+98 31 3261 1405
Email
Drmkrezaei_62@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Mansouri
Position
Associate Professor, Department of Anesthesiology, Isfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Heart Hospital, Bozorgmehr Bridge, third moshtagh Street
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1400
Fax
+98 31 3261 1405
Email
Drmkrezaei_62@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