The comparsion of propofol , thiopental with thiopental- propofol as induction drug on hemodynamic parameters of parturients and neonatal apgar during elective cesarean section
This is a randomized clinical trial to evaluate the effect of propofol, thiopental sodium and the combination of two drugs on neonatal apgar and hemodynamic parameters of in elective cesarean section.
This study was done on pregnant women who were candidates for elective cesarean section and
referred to Valiasr Hospital of Birjand. Inclusion criteria: Pregnant women with normal fetus and anesthesia class 1, 2. After the selection inclusion criteria the 84 patients were randomly divided into three groups of 28 subjects (propofol, thiopental sodium, thiopental sodium and propofol combined) groups. In the propofol group, propofol 2 mg /kg, in the thiopental group thiopental 4 mg /kg
and thiopental and propofol combined group propofol 1 mg /kg, thiopental 2 mg /kg were administered Intravenous. First and fifth minute Apgar score was recorded.
Also, the maternal hemodynamic parameters were measured before induction of anesthesia, after intubation for 12 minutes once every 3 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503166808N6
Registration date:2015-11-19, 1394/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-19, 1394/08/28
Registrant information
Name
Maryam Tolyat
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 9056
Email address
tolyatm@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-06-10, 1394/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparsion of propofol , thiopental with thiopental- propofol as induction drug on hemodynamic parameters of parturients and neonatal apgar during elective cesarean section
Public title
The effect of anesthesia on apgar score and maternal hemodynamic parameters after cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA Class 1 and 2; candidate for elective cesarean section; fetus is normal and full term.
Exclusion criteria: drug use by the mother; prolonged surgery; fetal abnormalities
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Street Ghaffari, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Approval date
2015-02-05, 1393/11/16
Ethics committee reference number
1009
Health conditions studied
1
Description of health condition studied
caesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Apgar score
Timepoint
First and fifth minute Apgar score
Method of measurement
Apgar test
2
Description
Blood pressure
Timepoint
before induction of anesthesia, after intubation for 12 minutes once every 3 minutes
Method of measurement
Blood pressure device
3
Description
pulse
Timepoint
before induction of anesthesia, after intubation for 12 minutes once every 3 minutes
Method of measurement
Monitoring device
4
Description
Oxygen saturation
Timepoint
before induction of anesthesia, after intubation for 12 minutes once every 3 minutes
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
In propofol group, propofol 2 mg /kg Intravenous for induction
Category
Treatment - Drugs
2
Description
The thiopental group thiopental 4 mg /kg Intravenous for induction
Category
Treatment - Drugs
3
Description
The thiopental and propofol combined group propofol 1 mg /kg , thiopental 2 mg /kg Intravenous for induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Malihe Zanguoie
Street address
Valiasr Hospital, Street Ghaffari, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzaadeh
Street address
Birjand University of Medical Sciences, Street Ghaffari, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
MSc in Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Street Ghaffari, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 3239 5453
Fax
Email
tolyatm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyat
Position
MSc in Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Street Ghaffari, Birjand, Jonoubi Khorasan, Iran
City
Birjand
Postal code
Phone
+98 56 3239 5453
Fax
Email
tolyatm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Tolyt
Position
MSc in Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Street Ghaffari, Birjand, Jonoubi Khorasan, Iran.
City
Birjand
Postal code
Phone
+98 56 3239 5453
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)