Comparative study of the effect of clonidine with placebo before surgery on hemodynamics and sedation of patients in stereotaxic surgery
Design
Clinical trial with control group with parallel groups, phase 2-3 on 72 patients
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients will be treated in two ways and the hemodynamics and sedation of patients will be recorded and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 and 65 years, conscious consent to enter the study, candidate for stereotaxic surgery, lack of drug sensitivity Exclusion criteria: changing the surgical plan for any reason, changing the anesthesia plan for any reason
Intervention groups
Intervention group: Patients in this group receive clonidine in a dose of 0.2 mg, 2 hours before the operation. Blood pressure and sedation of patients in this group will be measured in one, three, five, ten, fifteen minutes after the intervention and at the time of entering the recovery and every fifteen minutes in the recovery.
Control group: Patients in this group receive placebo tablets, which are very similar to clonidine, 2 hours before the operation. Blood pressure and sedation of patients in this group will be measured in one, three, five, ten, fifteen minutes after the intervention and at the time of entering the recovery and every fifteen minutes in the recovery.
Main outcome variables
Blood pressure and sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N2
Registration date:2021-07-12, 1400/04/21
Registration timing:prospective
Last update:2021-07-12, 1400/04/21
Update count:0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-10, 1400/05/19
Expected recruitment end date
2021-09-10, 1400/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of clonidine with placebo before surgery on hemodynamics and sedation of patients in stereotaxic surgery
Public title
Clonidine and hemodynamics and sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 65 years
Conscious consent to enter the study
Candidate for stereotaxic surgery
Lack of drug sensitivity
Exclusion criteria:
Changing the surgical plan for any reason
Changing the anesthesia plan for any reason
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-12-10, 1399/09/20
Ethics committee reference number
IR.MUI.MED.REC.1399.809
Health conditions studied
1
Description of health condition studied
Brain Tumor
ICD-10 code
C71.7
ICD-10 code description
Malignant neoplasm of brain stem
Primary outcomes
1
Description
Blood pressure
Timepoint
In minute one, three, five, ten, fifteen after the intervention and at the time of entering the recovery and every fifteen minutes in the recovery
Method of measurement
Measured by barometer
2
Description
Sedation
Timepoint
In minute one, three, five, ten, fifteen after the intervention and at the time of entering the recovery and every fifteen minutes in the recovery
Method of measurement
Richmond criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive clonidine in a dose of 0.2 mg, 2 hours before the operation. Blood pressure and sedation of patients in this group will be measured in one, three, five, ten, fifteen minutes after the intervention and at the time of entering the recovery and every fifteen minutes in the recovery.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive placebo tablets, which are very similar to clonidine, 2 hours before the operation. Blood pressure and sedation of patients in this group will be measured in one, three, five, ten, fifteen minutes after the intervention and at the time of entering the recovery and every fifteen minutes in the recovery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Mehrdad Masoudifar
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.