The purpose of this study will to determine Sequential compression pump effect on hypotension due to spinal anesthesia for cesarean section. Inclusion criteria: Women over 18 years of non-emergency or elective cesarean section. Exclusion criteria: emergency cesarean section; epidural anesthesia for cesarean; Multiple pregnancy; Pathology of pregnancy; valvular or ischemic heart disease or high blood pressure; sepsis; morbid obesity BMI>40; gestational diabetes and block level higher than T5. Study population and sample size: 76 patients scheduled for elective cesarean and assigned randomly to one of two groups pneumatic compression and controls.
After rehydration spinal anesthesia will performed with10 mg Marcaine and 2.5 mcg sufentanil thereafter the patients will placed supine with a 15 ° left lateral tilt. Cuff compression On position, in treatment group and Off in the control group. Initial outcome include blood pressure variations and secondary outcomes includes: ephedrine dose, the incidence of nausea & vomiting and required dose metoclopramide
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011217742N3
Registration date:2015-03-13, 1393/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-13, 1393/12/22
Registrant information
Name
Fatemeh Javaherforoosh Zadeh
Name of organization / entity
Ahvaz Joundishapoor University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 9315
Email address
javaherforosh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center Of Ahvaz University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sequential compression pump effect on hypo tension due to spinal anesthesia during cesarean section
Public title
Sequential compression pump effect on hypo tension due to spinal anesthesia during cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female over 18 years of non-emergency or elective cesarean section. exclusion criteria: emergency cesarean section; epidural anesthesia for cesarean; Multiple pregnancy; Pathology of pregnancy; valvular or ischemic heart disease or high blood pressure; sepsis; morbid obesity BMI>40; gestational diabetes; block level higher than T5
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Golestan street
City
Ahvaz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
ajums.REC.1393.271
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Mean blood pressure
Timepoint
From supine position every minute untill delivery and then every 3 minutes untill 10 minutes and then every 5 minutes untill arrival to recovery room and finally every 10 minutes untill discharge from recovery room
Method of measurement
sphygmomanometer
Secondary outcomes
1
Description
Efedrin dosage,Nousea and vomiting,Metocolopramid dosage
Timepoint
From spinal anesthesia to discharge from recovery room
Method of measurement
Mg,Frequency of occurrence N&V
Intervention groups
1
Description
sequestional compression device use in the intervention group after spinal anesthesia sequestional compression device
Category
Prevention
2
Description
No intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr.Fatemeh Javaherforoosh Zadeh
Street address
Felestin street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University Of Medical Science
Full name of responsible person
Dr.Nader Saki
Street address
Ahvaz University OfMedical Science
City
AhvZ
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?