Determining the effect of alprazolam and clonidine on the hemodynamic stability of patients under general anesthesia in the medical sciences hospitals of Tehran Azad University in 2024
Design
Clinical trial with control group, with phase 2 parallel groups, on 128 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study was conducted in 2024 at Bo Ali Hospital in Tehran. After general anesthesia, midazolam, fentanyl, sodium thiopental, and atracurium were administered during anesthesia. Intervention group: One hour before the operation, one group receives alprazolam tablets along with 50 cc of water. Intervention group: One hour before the operation, a clonidine group will be given. Then, at the end of the surgery, the patients will be reversed with neostigmine and atropine. At the beginning of the surgery, in the middle of the surgery and at the end of the surgery, the hemodynamic status of the patients is recorded by the nurse.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Electiveness of action؛
ASA1,2؛
Age 18-65 years؛
Sign a personal consent form to enter the study؛
Non-use of drugs, alcohol, cigarettes and psychotropic drugs
Exclusion criteria:
Loss of consciousness؛
The duration of the operation is more than 4 hours
Intervention groups
One hour before the operation, one group receives alprazolam tablets along with 50 cc of water and one group receives clonidine.
Main outcome variables
Systolic blood pressure؛
Diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240506061669N1
Registration date:2024-06-13, 1403/03/24
Registration timing:registered_while_recruiting
Last update:2024-06-13, 1403/03/24
Update count:0
Registration date
2024-06-13, 1403/03/24
Registrant information
Name
hamed hekmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 5731
Email address
hekmati.hamed@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Alprazolam (single dose) and Clonidine on improving the patient's stability under General Anesthesia
Public title
Comparing the effect of Alprazolam (single dose) and Clonidine on improving the patient's stability under General Anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elective surgery
ASA1,2
Age 18-65 years
Informed consent of the patient to enter the study
Non-use of drugs, alcohol, cigarettes and psychotropic drugs
Exclusion criteria:
Loss of consciousness
The duration of the operation is more than 4 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
At first, each patient was assigned a number, and then rand function of Excel software was used for randomization. The first half of the patients were in the alprazolam group and the second half were in the clonidine group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Islamic Azad University of Medical Sciences
Street address
Building of the Central Office of the Islamic Azad University of Tehran, located at the corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabir Street, Qolleh-Koochak intersection, Dr. Shariati Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.IAU.TMU.REC.1403.046
Health conditions studied
1
Description of health condition studied
Hemodynamic changes
ICD-10 code
T88.2
ICD-10 code description
Shock due to anaesthesia
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
At the beginning of the surgery, in the middle of the surgery and at the end of the surgery, the hemodynamic status of the patients is recorded by the nurse.
Method of measurement
Using operating room monitoring
2
Description
Diastolic blood pressure
Timepoint
At the beginning of the surgery, in the middle of the surgery and at the end of the surgery, the hemodynamic status of the patients is recorded by the nurse.
Method of measurement
Using operating room monitoring
3
Description
Mean arterial blood pressure
Timepoint
At the beginning of the surgery, in the middle of the surgery and at the end of the surgery, the hemodynamic status of the patients is recorded by the nurse.
Method of measurement
Using operating room monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One hour before the operation, one group receives alprazolam tablets along with 50 cc of water.
Category
Prevention
2
Description
Intervention group: One hour before the operation, a group receives clonidine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Hospital, Tehran
Full name of responsible person
Hamed hekmati
Street address
Buali hospital, damavand street, tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Hekmati.hamed@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Building of the Central Office of the Islamic Azad University of Tehran, located at the corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabir Street, Qolleh-Koochak intersection, Dr. Shariati Avenue, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Hekmati.hamed@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Hamed Hekmati
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Building of the Central Office of the Islamic Azad University of Tehran, located at the corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabir Street, Qolleh-Koochak intersection, Dr. Shariati Avenue, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Hekmati.hamed@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Hekmati
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Building of the Central Office of the Islamic Azad University of Tehran, located at the corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabir Street, Qolleh-Koochak intersection, Dr. Shariati Avenue, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Hekmati.hamed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Hekmati
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Building of the Central Office of the Islamic Azad University of Tehran, located at the corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabir Street, Qolleh-Koochak intersection, Dr. Shariati Avenue, Tehran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Hekmati.hamed@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD