Investigating the effects of etomidate, propofol and etomidate combined with propofol injections on hemodynamic changes in high blood pressure patients who are candidates for general anesthesia
Investigating the effects of etomidate, propofol and etomidate combined with propofol injections on hemodynamic changes in high blood pressure patients who are candidates for general anesthesia
Design
Clinical trial with parallel groups, double-blind, randomized, phase 3, on 150 patients. Excel software will be used for randomization.
Settings and conduct
This study aims to investigate the effects of etomidate, propofol and etomidate combined with propofol on hemodynamic changes in high blood pressure patients candidates for general anesthesia in abdominal surgeries in Fatemi Ardabil Hospital. The first group will receive propofol, the second group will receive etomidate, and the third group will receive etomidate and propofol. Blood pressure and heart rate will be evaluated in these patients. Patients and those evaluating the outcome will not know about the grouping done and the study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with blood pressure between 140/80 and 170/90 are candidates for abdominal surgery. Exclusion criteria: Patients with hemodynamic disorder who need therapeutic fluid and vasopressor.
Intervention groups
The intervention group will include patients with high blood pressure who are candidates for general anesthesia in abdominal surgeries, the first group will receive propofol (1.5-2 mg/kg), the second group will receive etomidate ( 0.3 mg/kg), and the third group will receive etomidate and propofol (propofol mg 1/kg and etomidate 0.15 mg/kg) and their blood pressure and heart rate will be checked after induction.
Main outcome variables
Blood pressure and heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231222060494N1
Registration date:2024-01-07, 1402/10/17
Registration timing:prospective
Last update:2024-01-07, 1402/10/17
Update count:0
Registration date
2024-01-07, 1402/10/17
Registrant information
Name
Somayye Najafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 7343
Email address
drsomayye@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of etomidate, propofol and etomidate combined with propofol injections on hemodynamic changes in high blood pressure patients who are candidates for general anesthesia
Public title
Effects of etomidate, propofol and etomidate combined with propofol on hemodynamic changes in high blood pressure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with blood pressure between 140/80 and 170/90 are candidates for abdominal surgery
Exclusion criteria:
Patients with hemodynamic disorder who need therapeutic fluid and vasopressor.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into three groups receiving propofol, etomidate and etomidate and propofol. Randomization in this study is done by simple randomization method using RAND function of Excel software. First, 150 random numbers are created in one column using the Rand function. Then, in the second column of the numbers from 1 to 150, a new random code is inserted in front of each column. Finally, in the third column, 50 lines with code A, 50 lines with code B, and 50 lines with code C are filled. After arranging the size of the numbers in the first column using the software, keeping their connection to the numbers in the second and third columns, the random sequence in the third column is ready. The numbers in the second column, each assigned to one of the three groups based on the corresponding line in the third column, can be used as the row code used in hiding.
Blinding (investigator's opinion)
Double blinded
Blinding description
In patients of the intervention groups, the form of drugs will be the same. Patients and doctors who evaluate the outcome will be unaware of the type of drug received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2023-12-04, 1402/09/13
Ethics committee reference number
IR.ARUMS.REC.1402.279
Health conditions studied
1
Description of health condition studied
Hemodynamic status
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
The first, fifth and tenth minutes after induction
Method of measurement
Vital signs monitoring device
Secondary outcomes
1
Description
Pulse rate
Timepoint
The first, fifth and tenth minutes after induction
Method of measurement
Vital signs monitoring device
Intervention groups
1
Description
Intervention group: The group receiving propofol 1.5-2 mg/kg (Tehran shimi Co)
Category
Treatment - Drugs
2
Description
Intervention group: The group receiving etomidate 0 3 mg/kg (Aboreihan Co)
Category
Treatment - Drugs
3
Description
Intervention group: The group receiving etomidate and propofol (propofol 1 mg/kg and etomidate 0.15 mg/kg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital in Ardabil
Full name of responsible person
Somayye Najafpour
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
fatemi@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Street address
Vice chancellor for research, Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4757
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Somayye Najafpour
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
drsomayye@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Somayye Najafpour
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
drsomayye@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Somayye Najafpour
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
drsomayye@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
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