Effect of General Anesthesia with Thiopental Sodium and Propofol on the 1 and 5 minute Apgar newborns by Cesarean
Design
The required number of samples in each group is 50, and a total of 100 people are in both groups.
In group A, for induction of anesthesia, 2.5 mg / kg propofol was used and in the group B 4 mg / kg Thiopental Sodium was used. Muscle Paralized for intubation was supplied by succinylcholine and maintenance of anesthesia with isoflurane 0.5 % And a mixture of oxygen and nitrous oxide are used. Atracurium is used in each group to maintain muscle relaxation. Examples of anesthesia induction intervals until embryo outflow is greater than 10 minutes or the interval between the uterus and the embryo is longer than 3 minutes are excluded. . In each group in the thirty seconds after the birth of the 5 heart rate factors - the condition of breathing and skin-tone of the muscle Reflex response ANIs are evaluated by the midwife whose currency is the type of medication and is recorded on the checklist.
The presence of nausea and vomiting during recovery is recorded by a recovery nurse.
Settings and conduct
OR of shahidan mobini Hospital in sabzevar city
Participants/Inclusion and exclusion criteria
AGE 18-35, ASA I ,II
Intervention groups
Pregnant women are divided randomly into two groups of thiopental sodium and propofol between the age of 18-35 under cesarean section.
Main outcome variables
1) Thiopental is effective on the first minute Apgar score in infants undergoing cesarean section surgery.
2) Thiopental is effective on the fifth minute apgar of neonates during cesarean section surgery.
3) Propofol affects the first-ever Apgar score of neonates in cesarean section surgery.
4) Propofol affects the 5th minute Apgar score in infants undergoing cesarean
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180307038985N1
Registration date:2018-05-15, 1397/02/25
Registration timing:retrospective
Last update:2018-05-15, 1397/02/25
Update count:0
Registration date
2018-05-15, 1397/02/25
Registrant information
Name
Manijeh Yousefi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 8595
Email address
yousefim@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
empty
Scientific title
Effect of General Anesthesia with Thiopental Sodium and Propofol on the 1 and 5 minute Apgar newborns by Cesarean
Public title
Effect of General Anesthesia with Thiopental Sodium and Propofol on the 1 and 5 minute Apgar newborns by Cesarean
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
age 18-35, ASA I, II
Exclusion criteria:
Diabet, over weight, addiction, bleeding, heart desease, pregnancy hypertention
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
Blinding (investigator's opinion)
Double blinded
Blinding description
detector, analizer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Azimian
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
ir.medsab.rec.1396.86
Health conditions studied
1
Description of health condition studied
Effect of general anesthesia on first and fifth minutes of Apgar in cesarean section
ICD-10 code
P91.8
ICD-10 code description
Other specified disturbances of cerebral status of newborn
Primary outcomes
1
Description
NeonateApgar
Timepoint
First &Fifth Min After Birth
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group": pofol, The dose of propofol is 5-2.5 mg / kg bolus and its maintenance dose is 300-100 mg / kg (once a kg / min). Continuous infusion is 1% solution ready for reconstitution.
Category
Treatment - Drugs
2
Description
Control group: Thiopental, The dose of Thiopental Sodium 5-3 mg / kg is given intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahidan Mobini Hospital
Full name of responsible person
DR Manijeh Yousefi Moghadam
Street address
Kashefi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1974
Email
yousefim@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Manijeh Yousefi Moghadam
Street address
Kashefi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1974
Email
yousefim@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
ManijehYousefi Moghadam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kashefi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4422 8595
Email
yousefim@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
ManijehYousefiMoghadam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kashefi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4422 8595
Email
yousefim@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Manijeh Yousefi Moghadam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kashefi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4422 8595
Email
yousefim@medsab.ac.ir
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
No - There is not 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
By sending an email
When the data will become available and for how long
After the article is published
To whom data/document is available
Author's email address
Under which criteria data/document could be used
For scientific research
From where data/document is obtainable
Author's email address
What processes are involved for a request to access data/document