Because vasovagal shock can occur as a result of seeing unpleasant scenes and the patient falls heavily on the ground and suffers physical injury and, on the other hand, with severe cardiac arrest and slowing heart rate has unpleasant consequences for the heart, it is controlled. Can be helpful.
Design
A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
This study is a double blind clinical trial that will be conducted in Khatam Al-Anbia Hospital of Shahroud in 1389-99.
Participants/Inclusion and exclusion criteria
conditions for entering:
Patient's informed consent to participate in the study
ASA II,III
Female or male aged 15 to 60 years
conditions for exiting:
People's unwillingness to participate in the study
History of heart disease
History of hypertension medications such as propranolol
History of cigarette alcohol abuse and any drug abuse
History of neurological disease
Intervention groups
It is designed to evaluate the prophylactic effect of atropine from vasovagal syncope before spinal anesthesia.
Main outcome variables
1. Determination of the association between vasovagal syncope and atropine injection in pre-regional anesthesia by age
2. Determination of the association between vasovagal syncope and atropine injection in pre-regional anesthesia by sex
3. Determination of the association between vasovagal syncope and atropine injection in pre-regional weight loss stage
4- Determination of the association between vasovagal syncope and atropine injection in pre-regional anesthesia according to blood pressure
5. Determination of the association between vasovagal syncope and atropine injection in pre-regional anesthesia in terms of phlebotomy rate
6. Determine the relationship between people's extreme fear of needles and the occurrence of vasovagal syncope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045957N1
Registration date:2020-02-29, 1398/12/10
Registration timing:registered_while_recruiting
Last update:2020-02-29, 1398/12/10
Update count:0
Registration date
2020-02-29, 1398/12/10
Registrant information
Name
Nazanin GolAlizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4269 1573
Email address
nazanin.glz7474@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of atropine on prevention of vasovagal syncope before spinal anesthesia
Public title
The effect of atropine on prevention of vasovagal syncope
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's informed consent to participate in the study
ASAII,III
Female or male aged 15 to 60 years
Exclusion criteria:
People's unwillingness to participate in the study
History of heart disease
History of hypertension medications such as propranolol
History of cigarette alcohol abuse and any drug abuse
History of neurological disease
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
We explain and consent to this intervention for the patient. But we don't talk to the patient about injecting placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Shahrood Branch
Street address
Semnan, Shahroud, Islamic Azad University, Central dormitory, next to the gas station
City
shahrood
Province
Semnan
Postal code
4318936199
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1398.036
Health conditions studied
1
Description of health condition studied
effect of atropine on prevention of vasovagal syncope
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Atropine
Timepoint
Before the intervention, 15 minutes after the intervention and one hour after the intervention
Method of measurement
Milligram and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bupivacaine Half Percent Spinal For Spinal Anesthesia. Atropine sulfate 0.5 mg drug from Tehran-Iran Pharmaceutical Manufacturing Company (IRC): 0931701432667660 We will use for the present study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam ol Anbia Hospital
Full name of responsible person
Yahyaii Behrouz
Street address
next to the gas station, Central dormitory,Islamic Azad University, Shahroud, ,Semnan
City
Shahroud
Province
Semnan
Postal code
4318936199
Phone
+98 23 3239 0360
Email
nazanin.glz7474@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. yahyaii.Behrouz
Street address
next to the gas station, Central dormitory,Islamic Azad University, Shahroud, ,Semnan
City
shahroud
Province
Semnan
Postal code
4318936199
Phone
+98 23 3239 0360
Email
nazanin.glz7474@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
researcher
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
Dr.Yahyaii.Behrouz
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
next to the gas station, Central dormitory,Islamic Azad University, Shahroud, ,Semnan
City
shahrood
Province
Semnan
Postal code
4318936199
Phone
+98 23 3239 0360
Email
nazanin.glz7474@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Kolookhi.Yousef
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
next to the gas station, Central dormitory,Islamic Azad University, Shahroud, ,Semnan
City
shahroud
Province
Semnan
Postal code
4318936199
Phone
+98 23 3239 0360
Email
dryousefkolookhianestezi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
GolAlizadeh.Nazanin
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
next to the gas station, Central dormitory,Islamic Azad University, Shahroud, ,Semnan
City
shahroud
Province
Semnan
Postal code
4318936199
Phone
009842691573
Email
nazanin.glz7474@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
empty
When the data will become available and for how long
empty
To whom data/document is available
empty
Under which criteria data/document could be used
empty
From where data/document is obtainable
empty
What processes are involved for a request to access data/document