The purpose of this study was to investigate the effect of induction type on newborn Apgar score. In this study, 230 women with ASA class 1 or 2 undergoing cesarean section were assigned to receive induction with either thiopental or propofol. Apgar score of newborns was checked at once and at the fifth minutes after birth and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010164947N1
Registration date:2010-11-22, 1389/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-22, 1389/09/01
Registrant information
Name
Mohammad Mahdi Dadras
Name of organization / entity
Zahedan University of Medical Siences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 54 1341 1260
Email address
dadras@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences and Health Services
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of propofol with thiopental as induction drug on neonatal Apgar during elective cesarean section
Public title
Induction effect on newborn Apgar score
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 1 or 2, age between 20 -40 years old, weight between 40 -100 kg
Exclusion criteria: hypertension, diabetes, opium addiction, heart disease, allergy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
230
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Research and Information Technology of Zahedan University of Medical Sciences an
Street address
Zahedan University Pardis of Medical siences and Health Services
City
Zahedan
Postal code
Approval date
empty
Ethics committee reference number
89-1158
Health conditions studied
1
Description of health condition studied
Elective cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Apgar score
Timepoint
at 1 and 5 minutes after birth
Method of measurement
Examination
Secondary outcomes
1
Description
nausea & vomiting of the mother
Timepoint
continuously
Method of measurement
Observation and asking the patients
2
Description
recovery
Timepoint
continuously
Method of measurement
examination
Intervention groups
1
Description
Administration of Propofol, 2mg/kg, and s.coline, 1.5 mg/kg, IV, then intubation and administration of Atracurrium, 0.5 mg/kg
Category
Other
2
Description
Administration of thiopental, 5mg/kg, and s.coline, 1.5 mg/kg, IV, then intubation and administration of Atracurrium, 0.5 mg/kg
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Mohammad Mahdi Dadras
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Maziar Mahjoobifard
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences and Health Services
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
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Mahdi Dadras
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital-
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
dadras@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Mazyar Mahjoobifard
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital -
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
dadras@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)