Comparison of the effect of dexmedetomidine and propofol sedation on sleep quality in patients after cardiac surgery
Design
The present study is a randomized clinical trial with parallel design.
Settings and conduct
Sampling will be done in Shahid Rajaei Hospital. Patients are randomly divided into two groups of propofol and dexmedetomidine in the intensive care unit.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age will be included in this study after cardiovascular surgery. These patients will be excluded from the study if they have previously received dexmedetomidine and propofol for initial sedation or an alternative sedative as a primary sedative, have had an organ transplant, or are pregnant or breastfeeding.
Intervention groups
Dexmedetomidine group
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161127031131N3
Registration date:2022-05-09, 1401/02/19
Registration timing:retrospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Rasoul Azarfarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2017
Email address
azarfarin@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
2021-05-22, 1400/03/01
Actual recruitment end date
2022-01-20, 1400/10/30
Trial completion date
2022-01-20, 1400/10/30
Scientific title
Comparison of the effect of sedation with dexmedetomidine and propofol on sleep quality in patients after cardiac surgery
Public title
Comparison of the effect of dexmedetomidine and propofol on how patients sleep after cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cardiovascular surgery aged above 18 years
Exclusion criteria:
If patients received both dexmedetomidine and propofol concomitantly for the primary sedation or an alternative agent as the primary sedation
Prior solid organ transplant
Pregnant patients
Lactating patients
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
118
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly assigned to two equal groups and for random assignment, permuted block randomization with quadruple blocks is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study do not know the group in which they are placed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shaheed Rajaie Cardiovascular Medical & Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.RHC.1400.048
Health conditions studied
1
Description of health condition studied
patients with coronary artery disease
ICD-10 code
I24.0
ICD-10 code description
Acute coronary thrombosis not resulting in myocardial infarction
Primary outcomes
1
Description
Evaluation of patient satisfaction with sedation during intubation
Timepoint
The drugs used will start after patients start to wake up, and 4-6 hours before the time of extubation in both groups .The Richmond Agitation and Sedation Scale (RASS) and Mary's Hospital Sleep Questionnaire used the day after operation in ICU.
Method of measurement
The Richmond Agitation and Sedation Scale (RASS) and Mary's Hospital Sleep Questionnaire and vital sign and patients lab data.
Secondary outcomes
1
Description
The effect of sedation on analgesia after extubation
Timepoint
Based on the Richmond Agitation and Sedation Scale (RASS), and Mary's Hospital Sleep Questionnaire (SMHSQ)which is a valid and reliable method for assessing patient sedation in the intensive care unit. And completing the questionnaire the next day.
Method of measurement
Richmond Agitation and Sedation Scale (RASS), and Mary's Hospital Sleep Questionnaire (SMHSQ) and completing a questionnaire on the duration of intubation and intensive care drugs like inoteropes
Intervention groups
1
Description
Control group: Propofol group: in this group we will infuse 50 μg/kg/min propofol in 6 hours (before the time of extubation ).The RASS will use to assess patients’ levels of sedation in all patients. Evaluation of sleep quality will study using Mary's Hospital Sleep Questionnaire.
Category
Treatment - Drugs
2
Description
Intervention group: Dexmedetomidine group: in this group we will infuse dexmedetomidine (precedex) will 0.5 μg/kg/h in 6 hours (before the time of extubation ).The RASS will use to assess patients’ levels of sedation in all patients. Evaluation of sleep quality will study using Mary's Hospital Sleep Questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular, Medical and Research Center
Full name of responsible person
Rasoul Azarfarin
Street address
Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2417
Email
azarfarin@rhc.ac.ir
Web page address
http://www.rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeideh Mazloomzadeh
Street address
Shaheed Rajaie Cardiovascular Medical & Research Center,
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
sa.mazloom@gmail.com
Web page address
http://rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Ghadimi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2417
Email
m_ghadimi@sums.ac.ir
Web page address
http://rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rasoul Azarfarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2417
Email
azarfarin@rhc.ac.ir
Web page address
http://rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rasoul Azarfarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rajaie Cardiovascular, Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2417
Email
azarfarin@rhc.ac.ir
Web page address
http://rhc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Data will be available after the article is published
To whom data/document is available
Information will be available to academic researchers
Under which criteria data/document could be used
Use of information is permitted provided the source is acknowledged
From where data/document is obtainable
Applicants can request the information they need by sending an email
What processes are involved for a request to access data/document
Information will be sent to them within one week of sending the email