Comparison effect of anesthesia type( spinal or general anesthesia) on Apgar score for newborns.
Design
A randomized, with parallel group trail with blinded outcome on 90 patients by permuted blind randomization
Settings and conduct
This study was carried out in Nik-Nafs Educational Hospital of Rafsanjan, Iran. Pregnant women were randomly divided into intervention and control groups. Babies in the control group were born under spinal anesthesia and named as group A, In the intervention group, they are given general anesthesia with thiopental-ketamine and named as group B. Therefore, the statistical analyst was blind to the study. Then the APGAR scores were recorded and compared in minutes 1-5-10-15.
Participants/Inclusion and exclusion criteria
Pregnant women candidate for elective cesarean section who born their infants with gestational age between 37-39 weeks included in the study.Infant born from mothers with the underlying disease like diabetes, hypertension and ...or with clinical sign of difficult intubation excluded from study.
Intervention groups
Newborn of mothers with gestational age 37-39 weeks under general anesthesia induced by thiopantal-ketamin
Main outcome variables
APGAR of newborn
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230703058656N2
Registration date:2024-06-27, 1403/04/07
Registration timing:retrospective
Last update:2024-06-27, 1403/04/07
Update count:0
Registration date
2024-06-27, 1403/04/07
Registrant information
Name
Bahar Noori-Rahmatabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 6194
Email address
baharnoori64@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of APGAR score for a newborn between spinal anesthesia and general anesthesia induced by thiopantal and ketamin
Public title
Effect of anesthesia in APGAR score for a newborn
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women candidate for elective cesarean section
Infants with gestational age between 37-39 weeks
Exclusion criteria:
Infant born from mothers with the underlying disease like diabetes, hypertension and ...
Infant born from mothers with clinical sign of difficult intubation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The lottery method was used for randomization. Thus, based on the lottery, the first person was placed in the spinal anesthesia group and the next person was placed in the general anesthesia group, and this process continued until the last person based on the sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Intervention group named as group A and control group as group B. So statistical analyst and outcome assessor were blind to the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Vice President researcher and Technology, Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2020-10-04, 1399/07/13
Ethics committee reference number
IR.RUMS.REC.1399.164
Health conditions studied
1
Description of health condition studied
Apgar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Apgar of newborn
Timepoint
One minute after birth, five minutes after birth, ten minutes after birth, fifteen minutes after birth
Method of measurement
Physical examination by anesthesiologist
Secondary outcomes
1
Description
Apgar score
Timepoint
One minute after birth, five minutes after birth, ten minutes after birth, fifteen minutes after birth
Method of measurement
Apgar scoring system
Intervention groups
1
Description
Intervention group 1: At first, medical history was taken and physical examination done. O2 therapy by face mask and cardiovascular monitoring done.General anesthesia by thiopental (dose=4mg/kg) and Ketamin(dose=1mg/kg) induced. Endotracheal tube placed and after that Apgar score register at 1-5-10minute after delivery time.
Category
N/A
2
Description
Control group: group 2: At first, medical history was taken and physical examination done. O2 therapy by face mask and cardiovascular monitoring done.spinal anesthesia by bupivacaine(dose=3.5-5mg) induced induced. Endotracheal tube placed and after that Apgar score register at 1-5-10minute after delivery time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebn_Abitaleb Hospital
Full name of responsible person
Mohammd-Ebrahim Pourhosseini
Street address
Taleghani Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
aliebn_hospital@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vasirinejad
Street address
Central Organization of Rafsanjan university of medical center
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0039
Email
vtrc@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mina Alipoor
Position
Educator
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Blvd
City
Rafsanjan
Province
Kerman
Postal code
77179 37555
Phone
+98 34 3428 0000
Email
minaalipoor22@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mina Alipoor
Position
Educator
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Blvd
City
Rafsanjan
Province
Kerman
Postal code
77179 37555
Phone
+98 34 3428 0000
Email
alipoormina22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mina Alipoor
Position
Educator
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Blvd
City
Rafsanjan
Province
Kerman
Postal code
77179 37555
Phone
0983434280000
Email
alipoormina22@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Sending data can only be done by presenting an official letter from institution.
From where data/document is obtainable
To receive information, refer to the Research Vice-Chancellor of Rafsanjan University of medical sciences.
What processes are involved for a request to access data/document
After the approval of the Research Vice-Chancellar of Rafsanjan University of medical sciences the data will be provided to the applicant.