Protocol summary

Summary
This study is designed for comparison of the depth of anesthesia with midazolam + Na thiopental and Midazolam + Propofol in cesarean section. 50 parturient will be operated under general anesthesia and depth of anesthesia will be measured by BIS. Major inclusion criteria are: parturient undergoing elective C/S ,age range 18-40 ,ASA Class I,II and Mallampati Class I,II and major exclusion criteria are: history of respiratory and cardiovascular disease,HTN, addiction, multiple gestation emergency C/S, predicted difficult airway.Primary outcome is depth of anesthesia. The patients are divided in two groups in from of double blind , both receive metoclopramide , 10mg,I.V, Midazolam 1.5mg IV and Lidocaine 1mg/kg I.V.Induction of general anesthesia and tracheal intubation(size 7,cuffed) with cricoids pressure is carried out in first group by Na thiopental 5mg/kg and succinylcholine 1.5 mg/kg and in second group by propofol 2.5mg/kg and succinylcholine 1.5mg/kg (Rapid sequence induction) BIS values as well as hemodynamic parameters is recorded at the time of standard monitoring installation , just before induction, after induction(just before laryngoscopy) 5 minutes after delivery and administering 1.5microg/kg fentanyl and 0.1 mg /kg morphine (I.V), when discontinuing volatile anesthetics and during extubation. The measures of two groups is compared there after. If hemodynamic instability or lightening of anesthesia occurred we will treat with appropriate intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105296625N1
Registration date: 2011-06-27, 1390/04/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-27, 1390/04/06
Registrant information
Name
Mozaffar Rabiee
Name of organization / entity
Babaol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
m_rabiee@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Science
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of depth of anesthesia with Midazolam+ Na Thiopental and Midazolam +Propofol in cesarean section
Public title
Comparison of depth of anesthesia with Midazolam+ Na Thiopental and Midazolam +Propofol in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients undergoing elective C/S; age range 18-40; ASA Class I,II; Mallampati class I,II Exclusion Criteria : History of respiratory and cardiovascular diseases; HTN; Addiction; Multiple Gestation; Emergency C/S; Predicted difficult airway
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethical Council of Babol University Of Medical Sciences
Street address
Ganjafrooz Avenue, Daneshgah Square , Ruhani Hospital
City
Babol
Postal code
Approval date
2011-02-15, 1389/11/26
Ethics committee reference number
3045/30/ژ/پ

Health conditions studied

1

Description of health condition studied
General anesthesia in Cesarean section
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery

Primary outcomes

1

Description
Depth of anesthesia
Timepoint
before intervention until end of surgery and extubation
Method of measurement
By Bispecteral Index System

Secondary outcomes

1

Description
BIS Values
Timepoint
At time of lying on surgical table, Induction , Intubation, Skin incision, 5 min after delivery and administering narcotics, discontinuing volatile anesthetics and extubation
Method of measurement
By Bispecteral Index System

2

Description
Hemodynamic parameters
Timepoint
At time of lying on surgical table, Induction , Intubation, Skin incision, 5 min after delivery and administering narcotics, discontinuing volatile anesthetics and extubation
Method of measurement
ECG, Pulse oximeter, Sphygmomanometer

3

Description
newborn APGAR Score
Timepoint
1 and 5 min after delivery
Method of measurement
Visual -Examination

4

Description
PH and Blood Gases in newborn umbilical Artery
Timepoint
After delivery
Method of measurement
Arterial Blood Gas

Intervention groups

1

Description
Metoclopramide10mg , Midazolam 1.5 mg , lidocaine 1.5mg/kg+ Propofol 2.5 mg/kg+ Succynil choline 1.5 mg/kg IV, single Dose
Category
Other

2

Description
Metoclopramide10mg , Midazolam 1.5 mg , lidocaine 1.5mg/kg+ Na thiopental 5 mg/kg+ Succynil choline 1.5 mg/kg IV, single Dose
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ruhani Medical & Educational Center
Full name of responsible person
Dr Seyed Mozaffar Rabiee
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Science
Full name of responsible person
Dr Amrolah Mostafanejad
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol University Of Medical Science
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
Babol University Of Medical Sciences
Full name of responsible person
Dr Seyed Mozaffar Rabiee
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue, Babol
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
drm_rabiee@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Seyed Mozaffar Rabiee
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue, Babol
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
drm_rabiee@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Seyed Mozaffar Rabiee
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue, Babol
City
Babol
Postal code
Phone
Fax
Email
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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