Comparison of outcomes between Propofol and Dexmedetomidine on extubation time and vital signs in patients with post- coronary artery bypass grafting in Open heart Intensive Care Unit
Overall Aim is to compare the effect of Dexmedetomidine and Propofol on extubation time and vital signs in patients undergoing coronary artery bypass grafting in the Intensive Care Unit Open Heart.The practical goal of this project is to select the right medication for sedation of post-CABG patients with fewer side effects, more efficient and more suitable for extubation.
Design
Clinical trial with a total of two parallel and equal groups, double-blind, randomized, on 92 patients. A block method was used for randomization
Settings and conduct
CABG candidate patients who are referred to Amirul Mominin Arak Hospital.Double-blind collection of vital signs and other variables. The patients are divided into two groups by anesthesiologist so the patient and the evaluator are not aware of the drug's name used in the groups
Participants/Inclusion and exclusion criteria
Terms and conditions of participation: Having informed consent Patients must meet inclusion criteria, i.e. be elective and referred for open heart surgery only.Age should be between 35 and 80 years old.Performed by the same surgeon.The maximum duration of the surgery must be 6 hours.All were operated with a cardiopulmonary pump.Valve surgery should not be performed at the same time as CABG
Exclusion conditions are: Patient is not a candidate for elective CABG surgery.Duration of surgery is more than 6 hours.Patients have not had surgery outside of the cardiopulmonary pump.Patients outside the 35-80 age range.The patient has the right to withdraw at any stage of the research
Intervention groups
Two equal groups of 46 people.
One group receives propofol medication and the other group receives dexmedetomidine medication, then the effect of these two medications on these two groups is measured.
Main outcome variables
Mean Arterial Pressure
Pulse rate
SpO2
Extubation time
Hospitalization time
Department hospitalization time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240207060924N1
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Taha Rafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
taharafiei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes between Propofol and Dexmedetomidine on extubation time and vital signs in patients with post- coronary artery bypass grafting in Open heart Intensive Care Unit
Public title
Effect of Propofol in coronary bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent
Patients must meet inclusion criteria, i.e. be elective and referred for open heart surgery only
Age should be between 35 and 80 years old
Performed by the same surgeon
The maximum duration of the surgery must be 6 hours
All were operated with a cardiopulmonary pump
Valve surgery should not be performed at the same time as CABG
Exclusion criteria:
Patient is not a candidate for elective CABG surgery
Duration of surgery is more than 6 hours
Patients have not had surgery outside of the cardiopulmonary pump
Patients outside the 35-80 age range
The patient has the right to withdraw at any stage of the research
Age
From 35 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will randomly divide 92 patients into two equal groups (P) and (D) using random block method.
The randomization unit will be done individually and we will use statistical software as a tool.
All statistical combinations that these two groups can have will be written. These combinations will include PPDD, PDDP, PDPD, DDPP, DPDP, DPPD. Now, using these combinations, the observations are placed into two intervention groups.
Note that the intervention groups are chosen blindly.
Blinding (investigator's opinion)
Double blinded
Blinding description
The aforementioned study is a double-blind study in which patients who meet the inclusion criteria and provide informed consent are assigned to one of two groups receiving Propofol (P) or Dexmedetomidine (D).
Patients are randomized into groups (P) and (D) by the anesthesiologist and are unaware of which group they are in.
In addition, the intern in charge of the project does not know the names of the groups.
After the patients wake up and become conscious and are extubated while the sedative infusion is stopped, the student in charge of the project will be present in the ward to fill in the questionnaires, so he will not know about the studied groups and will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij square, sardasht, Arak university of medical science
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.ARAKMU.REC.1402.212
Health conditions studied
1
Description of health condition studied
Comparison of Outcomes Between Propofol and Dexmedetomidine in Post-Coronary Artery Bypass Graft Patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean arterial blood pressure
Timepoint
Measurement of mean arterial blood pressure at 5, 15, 30, 45, 60, 90, 120, 150 minutes after entering the ward
Method of measurement
Pulse Oximeter
2
Description
Pulse rate
Timepoint
Measurement of pulse rate at 5, 15, 30, 45, 60, 90, 120, 150 minutes after entering the ward
Method of measurement
Pulse Oximeter
3
Description
Oxygen saturation
Timepoint
Measurement of Oxygen saturation at 5, 15, 30, 45, 60, 90, 120, 150 minutes after entering the ward
Method of measurement
Pulse Oximeter
4
Description
Extubation time
Timepoint
The duration of extubation from the time of admission to the Open Heart Intensive Care Unit
Method of measurement
Questionnaire
5
Description
Length of stay in the Unit
Timepoint
The duration of the stay in the Intensive Care Unit of the Open Heart surgery after the operation
Method of measurement
Questionnaire
6
Description
Length of hospitalization
Timepoint
The duration of the stay in the hospital
Method of measurement
Questionnaire
7
Description
Ramsay Score
Timepoint
Measurement of Ramsay score at 5, 15, 30, 45, 60, 90, 120, 150 minutes after admission to the unit
Method of measurement
Questionnaire
8
Description
Mortality
Timepoint
Measurement of the number of mortality events in the study population
Method of measurement
Questionnaire
9
Description
Age
Timepoint
Registration of patient age
Method of measurement
Questionnaire
10
Description
Sex
Timepoint
Registration of patient sex
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: (P) that we infuse 10 cc per hour (10 cc/hr) for 4 to 6 hours from a vial of propofol 10% (manufactured by B. Braun, Germany).
Category
Treatment - Drugs
2
Description
Second intervention group: (D) In the Dexmedetomidine group, the syringe pump is filled to a volume of 50 cc and Dexmedetomidine is infused at a dose of 20 µ/hour (manufactured by Elixir Lorestan, Iran) for 4 to 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Mo'menin Hospital
Full name of responsible person
Alireza Kamali
Street address
Amir Al Mo'menin Hospital, University campus, Basij square, Sardasht, Markazi, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 0000
Fax
+98 86 3417 3619
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Faculty of Medicine, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Taha Rafiei
Position
Student of medicine
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Faculty of medicine, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 3147
Email
taharafiei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of medicine, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
alikamaliir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Taha Rafiei
Position
Student of medicine
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Faculty of medicine, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be shared after study completion in accordance with ethical considerations
When the data will become available and for how long
Upon completion of the study
To whom data/document is available
The public is allowed access
Under which criteria data/document could be used
For scientific, research and therapeutic purposes
From where data/document is obtainable
first author
What processes are involved for a request to access data/document