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Comparison of depth of anesthesia in induction with sodium thiopental & propofol in elective cesarean section by BIS, IFT

Protocol summary

Summary
Objective: To compare the Depth of Anesthesia in induction with Sodium Thiopental & Propofol in Elective Cesarean Section by BIS, IFT. Inclusion criteria: 90 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; multiple gestation or preterm labor; fetal distress; neuromuscular diseases, opium addicts; history of multiple drug allergies or sensitivity to anesthetics; bradycardia and heart block. Intervention:90 patients divided into two groups P or T: Anesthesia will induce by Thiopental (5-4 mg / kg) in group T and Propofol (2.5-2 mg / kg) in group P and Scholin (2 mg / kg) and is going to maintain with 50% N2O, O2, Sevoflurane 2% and after birth by N2O 50%, O2, sevoflurane 1.2%,a blood pressure cuff will fasten on the dominant arm and inflated (200 mmHg) immediately before administering the drugs. After induction, a recorded message will be played once by the headphones every 1 minute to move the fingers of the dominant hand. Hand movement will be scored as follows after playing message: No movement: zero /uncertain movements: open and close the fingers: 2 before induction of anesthesia, BIS sensor device will be installed according to the manufacturer's instructions on the forehead of the patient. BIS values and IFT following events will be recorded at baseline, Induction of anesthesia, laryngoscopy and intubation, Skin incision, opening the peritoneum, Uterine incision, childbirth Uterine closure, , tying the layers under the skin, Subcutaneous closures, skin closure, turn off the gas anesthesia, eye opening and extubation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082819470N44
Registration date: 2016-12-21, 1395/10/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of depth of anesthesia in induction with sodium thiopental & propofol in elective cesarean section by BIS, IFT
Public title
Comparison of depth of anesthesia in induction with sodium thiopental & propofol in elective cesarean section by BIS, IFT
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: 90 pregnant women (ASA I- II) who are under general anesthesia for elective cesarean section. Exclusion criteria: Patients who are not properly cooperate; patients who received magnesium sulfate MgSO4 before the study; mental disorders; Patients who have a history of previous awareness during general anesthesia, patients who take blood pressure medication or patients who require the use of vasodilators or vasodepressor drugs; patients who consume human stimulant or psychotropic drugs; mothers with multiple gestation or preterm labor; fetal distress, patients with neuromuscular diseases, opium addicts; history of multiple drug allergies or sensitivity to anesthetics; patients with bradycardia and heart block.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2014-11-16, 1393/08/25
Ethics committee reference number
CP-P-9364-6484

Health conditions studied

1

Description of health condition studied
caesarean section
ICD-10 code
082.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
To determine the depth of the anesthesia bySodium Thiopental and Propofol as an induction anesthetic
Timepoint
at baseline, Induction of anesthesia, laryngoscopy and intubation, Skin incision, opening the peritoneum, Uterine incision, childbirth Uterine closure, , tying the layers under the skin, Subcutaneous closures, skin closure, turn off the gas anesthesia, eye opening and extubation.
Method of measurement
bispectral index (BIS) and Isolated forearm technique (IFT)

Secondary outcomes

empty

Intervention groups

1

Description
Group T: Anesthesia will induce by rapid sequence method with administration of Thiopental (5-4 mg / kg) in group T and Scholine (2 mg / kg) and cricoid pressure. Anesthesia until the birth will maintain with 50% N2O, O2, Sevoflurane 2% and after birth by N2O 50%, O2, sevoflurane 1.2%, midazolam 0.03 mg / kg, morphine 0.1 mg / kg and Cisatracurium 0.04 mg / kg for muscle relaxation.
Category
Treatment - Drugs

2

Description
Group P: Anesthesia will induce by rapid sequence method with administration of Propofol (2.5-2 mg / kg) in group P and Scholine (2 mg / kg) and cricoid pressure. Anesthesia until the birth will maintain with 50% N2O, O2, Sevoflurane 2% and after birth by N2O 50%, O2, sevoflurane 1.2%, midazolam 0.03 mg / kg, morphine 0.1 mg / kg and Cisatracurium 0.04 mg / kg for muscle relaxation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Maryam Beihaghi
Street address
Hafez Hospital, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Beihaghi
Position
anesthesiology resident/physician
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
beihaghim@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Mohammad Reza Hadavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Namazi square, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
hadavimr@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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