Comparison of sedation effects of dexmedetomidine and propofol on patients requiring mechanical ventilation in ICU
Design
Clinical trial with two parallel groups of 35, double-blind, randomized, phase 3 on 70 patients, randomization method with 4 permuted block randomization
Settings and conduct
Patients admitted to the ICU of Ayatollah Rouhani Hospital in Babol, who were included in the study will be divided into two groups, dexmedetomidine and propofol, and receive specified doses of the drug, and the relevant parameters will be recorded during specified time intervals. Patients will be followed up to 24 hours and hemodynamic changes, pain, level of consciousness, etc. will be compared in two groups.
On the paper label, random codes are written without a specific order and framework, which is the identification number of the relevant treatment, and the list of which will only be available to the ICU nurse. The evaluator, the statistician, and the patient will be blinded.
Participants/Inclusion and exclusion criteria
patients over 18 years old who need to be intubated and be sedated after surgery and stay in ICU for at least 24 hours.
Intervention groups
Patients will be divided into two groups, dexmedetomidine and propofol, and will receive specified doses of the drug.
Main outcome variables
Need for narcotic drug (fentanyl)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230828059291N1
Registration date:2023-09-09, 1402/06/18
Registration timing:prospective
Last update:2023-09-09, 1402/06/18
Update count:0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Amir hossein Saadati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 754 2722
Email address
asaadati1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-14, 1402/06/23
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomidine and propofol for sedation in patients requiring mechanical ventilation in ICU: A randomized clinical trial
Public title
comparison of dexmedetomidine and propofol sedation in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients over 18 years old
staying in ICU for at least 24 hours after surgery
need to be intubated and be sedated
Exclusion criteria:
Hypotension (SBP<90)
pregnant women
obesity (body weight more than 50% higher than ideal body weight)
ESRD patients
Glasgow Coma Scale (GCS) below 12 (moderate and severe brain damage)
Significant arrhythmia or high degree of atrioventricular node block
patients who are allergic to the drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is Permuted Block Randomization, which is set as blocks of 4 (AABB). Then, using Excel software, a number is randomly assigned to each of the letters in the block, and then the letters A and B are arranged based on the size of the number that came randomly and form a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The list of random allocation of patients will only be available to the ICU nurse. In order to hide the random assignment process, random codes are written on the paper label without a specific order and frame, which is the identification number of the relevant treatment, and the list will be available only to the ICU nurse. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the nurse will provide the patient with the treatment package. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2023-08-27, 1402/06/05
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.071
Health conditions studied
1
Description of health condition studied
Sedation in ICU patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
comparison of the need for narcotic drug (fentanyl) in dexmedetomidine and propofol groups
Timepoint
The amount of injected fentanyl will be measured at the end of 24 hours.
Method of measurement
The amount of fentanyl injection will be recorded during the study.
Secondary outcomes
1
Description
Hemodynamic parameters (systolic and diastolic blood pressure, heart rate, mean arterial blood pressure)
Timepoint
Hemodynamic parameters will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours.
Method of measurement
The monitoring device
2
Description
Respiratory parameters (respiratory rate, spontaneous breathing and airway pressure)
Timepoint
Respiratory parameters will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours.
Method of measurement
The mentioned variables are measured by ventilator devices and then recorded at the time intervals.
3
Description
Level of consciousness
Timepoint
The level of consciousness will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours.
Method of measurement
The level of consciousness will be measured by Ramsay Sedation Scale.
Intervention groups
1
Description
Intervention group 1: Group A will receive ِDexmedetomidine with a loading dose of 1 µg/kg for 10 minutes followed by a maintenance infusion of 5 µg/kg/hr (0.2-0.7 µg/kg/hr). If the target level of RSS (4 and 5 ) was not obtained or maintained; A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: Group B will receive Propofol with an infusion of 2 mg/kg/hr (1-3 mg/kg/hr). If the target level of RSS (4 and 5) is not achieved or maintained; A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatollah Rouhani Hospital
Full name of responsible person
Amirhossein Saadati
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Pouya Tayyebi
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Amir Hossein Saadati
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Motahari st, Andishe 16 alley, 4714957197
City
Babol
Province
Mazandaran
Postal code
4714957197
Phone
+98 911 754 2722
Fax
Email
Asaadati1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amir Hossein Saadati
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Motahari st, Andishe 16 alley, 4714957197
City
Babol
Province
Mazandaran
Postal code
4714957197
Phone
+98 911 754 2722
Fax
Email
Asaadati1997@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amir Hossein Saadati
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Motahari st, Andishe 16 alley, 4714957197
City
Babol
Province
Mazandaran
Postal code
4714957197
Phone
+98 911 754 2722
Fax
Email
Asaadati1997@gmail.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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the study will be published.
When the data will become available and for how long
End of the study
To whom data/document is available
The documentation will be accessible to everyone.
Under which criteria data/document could be used
No special conditions are considered.
From where data/document is obtainable
asaadati1997@gmail.com
What processes are involved for a request to access data/document