Protocol summary

Study aim
General purpose: Comparison of the effect of midazolam and clonidine one hour before general anesthesia in more favorable hemodynamic stability of the patient in medical sciences hospitals of Azad University of Tehran.
Design
Clinical trial in two groups, double blind, randomized, on 128 patients. The operating room list was used for randomization.
Settings and conduct
Record the hemodynamics of the patients before the intervention and then in the clonidine group orally and in the second group midazolam intramuscularly with breathing control and pulse oximeter probe and auxiliary oxygen available; Do anesthesia one hour before induction. Then at different times after airway management, measure and record hemodynamics and finally compare the results of the two groups.
Participants/Inclusion and exclusion criteria
1- Patient cooperation to enter the study community 2- The possibility of follow-up and availability of patients in the determined time intervals 3- Non-use of drugs and stimulants 4- No history of allergy to midazolam and clonidine 5- Absence of cognitive disorders 6- Patients aged 18 to 50 with class asa above 2
Intervention groups
In this study, we decided and tried to randomly select all people between the ages of 18 and 50 and of any gender who refer to the operating rooms of Azad University Hospitals for general anesthesia.
Main outcome variables
systolic blood pressure; Diastolic blood pressure, mean blood pressure, arterial oxygen saturation level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240503061642N1
Registration date: 2024-08-17, 1403/05/27
Registration timing: retrospective

Last update: 2024-08-17, 1403/05/27
Update count: 0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
abdollah mousavi ouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5536 8847
Email address
dr.mousavi.radiologist68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of midazolam and clonidine on the hemodynamic stability of patients under general anesthesia
Public title
comparing the effect of midazolam and clonidine on improving the patient's satability One hour before general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patient cooperation to enter the study community2- The possibility of follow-up and availability of patients in the determined time intervals3- Non-use of drugs and stimulants4- No history of allergy to midazolam and clonidine5- Absence of cognitive disorders6- Patients aged 18 to 50 with class asa above 2
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we decided and tried to randomly select all people between the ages of 18 and 50 years and of any gender who refer to the operating rooms of Azad University Hospitals for general anesthesia. On the same day, they will be put under general anesthesia in the operating room in turn, and we will put them in two groups and select an equal number of them.
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
Ethical Committee of Faculty of Medicine - Islamic Azad University of Medical Sciences, Tehran
Street address
5u-17 no- ave. mohammadi- ave forozesh-qtr monireh-street valiasr
City
tehran
Province
Tehran
Postal code
1195613886
Approval date
2024-05-13, 1403/02/24
Ethics committee reference number
IR.IAU.TMU.REC.1402.257

Health conditions studied

1

Description of health condition studied
patient Hemodynamic
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hemodynamic changes
Timepoint
at 1 and 3 minutes after induction of anesthesia and 1,3,5 and 10 minutes After airway management
Method of measurement
Blood pressure monitoring and pulse oximeter device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group 1: Received intravenous midazolam (an anesthetic medication) via ampule.Group 2: Received oral clonidine (a medication used to treat high blood pressure, anxiety, and sleep disorders) in pill form.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bo'ali Hospital Islamic Azad University of tehran
Full name of responsible person
Dr. Giti Dehghan Manshadi
Street address
Islamic Azad University, Medical Sciences Branch, Tehran shaariati St., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Manshadi_gd@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Giti Dehghan Manshadi
Street address
Islamic Azad University Tehran Medical Sciences, Shariati St, , International Faculty
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
shahabpour_golaleh@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
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
Islamic Azad University
Full name of responsible person
abdollah mousavi ouri
Position
General medical student
Latest degree
Master
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University Tehran Medical Sciences, Shariati St, , International Faculty
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 5536 8847
Email
mousavi.nurse91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Giti Dehghan Manshadi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Azad University Tehran Medical Sciences, Shariati St, , International Faculty
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Manshadi_gd@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
abdollah mousavi ouri
Position
دانشجوی پزشکی عمومی
Latest degree
Master
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University Tehran Medical Sciences, Shariati St, , International Faculty
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 5536 8847
Email
mousavi.nurse91@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
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