The survey of the effect of acupuncture on the hemodynamic-profile after spinal anesthesia for cesarean section
Design
Clinical traial with acontrol group, double blinded with randomized parallel groups
Settings and conduct
In the general hospital pregnant women candidates for elective ceasarean section with spinal anesthesia enter the study. Before spinal anesthesia, in the first group, electroacupuncture is performed for 10 minutes. In the placebo group,leads attached to the points indicated and electroacpuncture device isnot turned on..In the control group BP and PR monitoring is performed without any intervention.
Participants/Inclusion and exclusion criteria
Patients undergoing cesarean section with spinal anesthesia between the ages of 18-45 and the gestational age of 38-39 weeks are included in the study. Patients with preeclampsia/twin or multiple/severe obesity/taking steroids/ diabetes and patients outside the age 18-45 and preterm pregnancy are excluded from the study.
Intervention groups
Patients who meet the conditions for entering the study are in one of three groups (acupuncture/ placebu/ control). In the acupuncture group, both hands at the p6 point before the spinal anesthesia, electroacupuncture are performed for 10 minutes.The placebo group ,leads is clinging to the points mentioned and attached to electroacupuncture device but device is not turned on. For the control group only PR/BP is monitored but nothing is performed.
Main outcome variables
Time before intervention up to 5 minutes after spinal anesthesia,Hypotention after spinal anesthesia, bradycardia after spinal anesthesia, need for vasopressor after spinal anesthesia, nausea after spinal anesthesia, vomiting after spinal anesthesia.
General information
Reason for update
Acronym
EAHSACS
IRCT registration information
IRCT registration number:IRCT20181011041308N2
Registration date:2019-10-26, 1398/08/04
Registration timing:registered_while_recruiting
Last update:2019-10-26, 1398/08/04
Update count:0
Registration date
2019-10-26, 1398/08/04
Registrant information
Name
Mahmoud Reza Alebouyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 6136
Email address
alebuieh.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupuncture on Hemodynamic_profile after Spinal Anesthesia during Cesarean Section
Public title
The Effect of Acupuncture on Hemodynamic_profile after Spinal Anesthesia during Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with elective cesarean section with spinal anesthesia without a history of disease
Age of 18-45 years old
Gestational age: 38-39 weeks
Exclusion criteria:
Pregnant women with preeclampsia/high blood pressure/out of range 18-45/gestational age 38-39 weeks
diabetes/severe obesity /taking more than 5 mg of prednisone/multiple pregnancy/
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who evaluates the outcome is unaware of the interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2019-05-22, 1398/03/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.115
Health conditions studied
1
Description of health condition studied
Hemodynamic profile chenges after spinal anesthesia through cesarean section of pregnant women.
ICD-10 code
I95
ICD-10 code description
Hypotension
Primary outcomes
1
Description
The changes of mean arterial pressure
Timepoint
Before spinal anesthesia and immediately after spinal anesthesia and after 5,10,15,20,25,and 30 minutes respectively after spinal anesthesia
Method of measurement
Non invasive blood pressure
2
Description
The changes heart rate
Timepoint
Before spinal anesthesia and immediately after spinal anesthesia and after 5,10,15,20,25,and 30 minutes respectively after spinal anesthesia
Method of measurement
HR monitorng
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group the patients are electroacupunctured in p6 point before spinal anesthesia for ten minutes.
Category
Treatment - Other
2
Description
Control group: in this group the leads of electrooccupuncture are attached in p6 point but the device is not turned on .
Category
Other
3
Description
Control group: in this group patients are monitored after and before spinal anesthesia due to the changes of BP and heart rate without doing any actions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Mahmud Reza Alebuieh
Street address
Rasool Akram hospital. Niayesh ave., Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 2326 6435
Fax
Email
alebuieh.mr@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahmudrezaalebuieh
Street address
Rasool Akram hospital. Niayesh ave., Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
Email
alebuieh.mr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahmud Reza Aleuieh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram hospital. Niayesh ave., Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 232664352198
Email
alebouyeh@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahmudreza Alebuieh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram hospital. Niayesh ave., Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
0098212326643521
Email
alebuieh.mr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rashin Taghizadehkohneshahri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram hospital. Niayesh ave., Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 4409 5035
Email
taghizadehrashin@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
information about the main and secondary outcom
When the data will become available and for how long
start the access period immediatly after printing the results
To whom data/document is available
only individuals and academic institutions
Under which criteria data/document could be used
The result of any analysis without harmonization and permission is not published
From where data/document is obtainable
alebuieh.mr@iums.ac.ir
What processes are involved for a request to access data/document
The request from academic university will be answered within ten business days.