Protocol summary
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Study aim
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Objective:Comparison of two different doses of thiopental sodium in elective cesarean section (C/S) under general anesthesia on depth of anesthesia with Isolated Forearm Technique (IFT) and on neonatal neurobehavioral test
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Design
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Double blind randomized clinical trial
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Settings and conduct
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patients divided into two groups one or two in the Hafeiz Hospital .Induction of anesthesia will be with Thiopental (5mg / kg) in group one and Thiopental (7 mg / kg) in group two and Scholin (2 mg / kg) , maintenance was with 50% N2O, 50%O2, Sevoflurane and after birth by N2O 50%, O2 50%, sevoflurane.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: pregnant women (ASA I- II) who are under general anesthesia for elective cesarean section.Exclusion criteria: patients who are not properly cooperate; prior use of sulfate MgSO4; mental disorders; a history of previous awareness during general anesthesia, taking blood pressure medication or vasodilators or vasodepressor and human stimulant or psychotropic drugs; neuromuscular diseases, opium addicts; detection of any fetal abnormalities by ultrasonography.
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Intervention groups
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80 patients divided into two groups : Induction of anesthesia will be with Thiopental (5mg / kg) in group one and Thiopental (7 mg / kg) in group two and Scholin (2 mg / kg) , maintenance was with 50% N2O,50%O2, Sevoflurane
and after birth by N2O 50%, 50%, sevoflurane.
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Main outcome variables
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The depth of the anesthesia
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016082819470N45
Registration date:
2017-07-28, 1396/05/06
Registration timing:
prospective
Last update:
2019-03-13, 1397/12/22
Update count:
1
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Registration date
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2017-07-28, 1396/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research, Shiraz University of Medical Sciences
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Expected recruitment start date
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2017-08-25, 1396/06/03
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Expected recruitment end date
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2017-11-24, 1396/09/03
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of two different doses of thiopental sodium in elective cesarean section (C/S) under general anesthesia on depth of anesthesia with Isolated Forearm Technique (IFT) and on neonatal neurobehavioral test
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Public title
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Comparison of two different doses of thiopental sodium in elective cesarean section (C/S) under general anesthesia on depth of anesthesia with Isolated Forearm Technique (IFT) and on neonatal neurobehavioral test
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged between 15-50
pregnant women undergoing cesarean section
ASA I-II
Exclusion criteria:
Patients who are not properly cooperate
Prior use of sulfate MgSO4
Mental disorders
History of previous awareness during general anesthesia
Taking blood pressure medication or vasodilators or vasodepressor and human stimulant or psychotropic drugs
Neuromuscular diseases
Opium addiction
Fetal abnormalities by ultrasonography
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Age
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From 15 years old to 50 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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An anesthesia nurse is providing the Thiopental syringe to the anesthesiologist for induction of anesthesia .The anesthesiologist who are responsible for injecting Thiopental is aware of the study groups while the another anesthesiologist who will assess the mothers and infants during the study is unaware of the study groups .
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-11-16, 1393/08/25
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Ethics committee reference number
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CT-P-9362-6822
Health conditions studied
1
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Description of health condition studied
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caesarean section
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ICD-10 code
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082.0
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ICD-10 code description
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Delivery by elective caesarean section
Primary outcomes
1
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Description
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To determine the depth of the anesthesia by Sodium Thiopental and Propofol as an induction anesthetic
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Timepoint
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at baseline, Induction of anesthesia, laryngoscopy and intubation, Skin incision, opening the peritoneum, Uterine incision, uterine retraction, childbirth, Uterine closure, tying the layers under the skin, Subcutaneous closures, at the start of skin closure,2 minutes after skin closure, eye opening and extubation.
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Method of measurement
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Bispectral index (BIS) and Isolated forearm technique (IFT
Secondary outcomes
1
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Description
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neonate Apgar
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Timepoint
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at 0, 5, and 20 minutes after birth
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Method of measurement
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Apgar score
2
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Description
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Neurobehavioral test
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Timepoint
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20 minutes after birth
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Method of measurement
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Neurobehavioral test
Intervention groups
1
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Description
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Group one: Anesthesia will induce with administration of Thiopental (5 mg / kg) in group one and Scholine (2 mg / kg) will maintain with 50% N2O, O2, Sevoflurane and by N2O 50%, O2, sevoflurane after birth.
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Category
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Treatment - Drugs
2
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Description
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Group two: Anesthesia will induce with administration of Thiopental (7mg / kg) in group one and Scholine (2 mg / kg) will maintain with 50% N2O, O2, Sevoflurane and by N2O 50%, O2, sevoflurane after birth.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available