Comparing the effects of propofol and dexmedetomidine on hemodynamic changes and delirium in trauma patients
Design
.
Settings and conduct
In the ICU of Ali Bin Abitalib Hospital in Rafsanjan
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study include all trauma patients in the ICU, and the age range of 18-55 years and the presence of an informed companion are considered as inclusion criteria. They are randomly distributed
And the exclusion criteria include patients with unstable hemodynamics and drug sensitivity to propofol (due to the possibility of delayed seizures, the patient should be cared for until one day after the operation) as well as patients with a history of drug abuse, drug abuse, or Alcohol dependence, history of neurological, neuromuscular or psychiatric diseases, especially history of seizures or epilepsy, history of pulmonary and cardiovascular diseases, long-term and chronic use of pain relievers including cyclooxygenase 2 inhibitors are also excluded from the study.
Intervention groups
There are 40 trauma patients with an age range of 18-55 years
Main outcome variables
Hemodynamic changes and delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190117042390N2
Registration date:2023-10-12, 1402/07/20
Registration timing:retrospective
Last update:2023-10-12, 1402/07/20
Update count:0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Seed hamid Pakzad moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 5983
Email address
dr.pakzad@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-16, 1401/06/25
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
2023-03-16, 1401/12/25
Actual recruitment end date
2023-03-16, 1401/12/25
Trial completion date
2023-03-16, 1401/12/25
Scientific title
Compare effects propofol and dexmedetomidine in hemodynamic Changes and delirium in trauma patients in the ICU
Public title
Compare effects propofol and dexmedetomidine in hemodynamic Changes and delirium in trauma patients in the ICU of Ali Ebn Abitaleb Hospital of Rafsanjani years 2023
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The entry criteria for the study, including all people with trauma in the ICU, and the age range of 18-55 years and the presence of a companion, will be considered as the entry criteria. They are distributed randomly
Exclusion criteria:
Age
From 18 years old to 55 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was simple random and until the completion of the sample size among eligible clients. Then, the samples are divided into two similar groups of 20 people, dexmedetomidine and propofol, using the table of random numbers.
And they are divided into two groups D and P and they are placed in one of the two groups according to the order of entry into the study (even and odd).
Blinding (investigator's opinion)
Single blinded
Blinding description
There are 40 trauma patients with an age range of 18-55 years.
The study subjects will be divided into two groups of 20 people receiving dexmedetomidine and propofol, and hemodynamic changes and delirium will be investigated.
Placebo
Used
Assignment
Crossover
Other design features
And the exclusion criteria include patients with unstable hemodynamics and drug sensitivity to propofol (due to the possibility of delayed seizures, the patient should be cared for until one day after the operation) as well as patients with a history of drug abuse, drug abuse, or Dependence on alcohol, history of neurological, neuromuscular or psychiatric diseases, especially history of seizures or epilepsy, history of pulmonary and cardiovascular diseases, long-term and chronic use of pain relievers including cyclooxygenase 2 inhibitors are also excluded from the study. used in This research consists of: 1- Propofol with the brand name Pofol (it is a drug that is used by short-acting intravenous injection method and causes a decrease in the level of consciousness or anesthesia. This drug is used to start anesthesia and also maintain anesthesia during surgery. and in the form of 20ml ampoules containing 1% propofol. Due to the use of emulsion, soy and egg, a history of sensitivity to these substances can indicate sensitivity to propofol. 2- Dexmedetomidine, which is a sedative drug and is used in patients who are carefully are under medical care and require mechanical ventilation. Dexmedetomidine is administered as a slow intravenous injection by the medical staff using a slow drug injection device, and it contains 200 mg of dexmedetomidine in ampoules of 20 ml.
Secondary Ids
1
Registry name
مرکز تحقیقات عوامل اجتماعی موثر بر سلامت
Secondary trial Id
401014
Registration date
2023-04-18, 1402/01/29
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Meraj - Alley65
City
Rafsanjan
Province
Kerman
Postal code
7737144559
Approval date
2022-09-14, 1401/06/23
Ethics committee reference number
IR.RUMS.REC.1401.178
Health conditions studied
1
Description of health condition studied
head trauma patients
ICD-10 code
S00-S09
ICD-10 code description
تروما به سر
2
Description of health condition studied
thorax trouma
ICD-10 code
520-529
ICD-10 code description
ترومای قفسه سینه
Primary outcomes
1
Description
Hemodynamic changes and delirium
Timepoint
3 months
Method of measurement
This study is a clinical trial study that will be conducted on 40 trauma patients with an age range of 18-55 years, divided into two groups, that is, under anesthesia with propofol and under anesthesia with dexmedetomidine. In the end, 20 people from each group will be tested for a total of 40 people. Considering the first type error of 5% and the power of 80% and the ability to show the average difference between the two groups that is statistically significant (size effect = 0.5), 20 cases were considered for each group.
Secondary outcomes
1
Description
Hemodynamic changes and delirium
Timepoint
16-12-24-48 hours after starting the drug
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group:Two groups of 20 people receiving dexmedetomidine and propofol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Bin Abitalib Hospital
Full name of responsible person
Hamid Pakzad Moghadam
Street address
St 64 Meraj
City
Rafsanjan
Province
Kerman
Postal code
7737144459
Phone
+98 913 156 4386
Fax
+98 34 3428 0038
Email
pakzadmoghadam@gmail.com
Web page address
https://www.rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyed Hamid Pakzad Moghadam
Street address
North Meraj 64
City
Rafsanjan
Province
Kerman
Postal code
7737144459
Phone
+98 913 156 4386
Fax
+98 34 3428 0038
Email
pakzadmoghadam@gmail.com
Web page address
https://www.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyed Hamid Pakzad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Meraj 64
City
Rafsanjan
Province
Kerman
Postal code
7737144459
Phone
+98 34 3428 0042
Email
pakzadmoghadam@gmail.com
Web page address
https://www.rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
hamid pakzad moghadam
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
meraj 64
City
Rafsanjan
Province
Kerman
Postal code
7737144459
Phone
+98 34 3428 0042
Email
pakzadmoghadam@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
hamid pakzad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
meraj64
City
Rafsanjan
Province
Kerman
Postal code
7737144459
Phone
009834340042
Email
pakzadmoghadam@gmail.com
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
If the request is received, the desired information will be sent via email
When the data will become available and for how long
Up to one year after publication
To whom data/document is available
hamid pakzad
Under which criteria data/document could be used
If there is a request from official sources to use new research in line with the topic under study
From where data/document is obtainable
Send to the responsible author's email
What processes are involved for a request to access data/document
Sending to email, checking and verifying the test and resending to the requester