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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ChiCTR
Last refreshed on:	18 April 2017
Main ID:	ChiCTR-TRC-12002439
Date of registration:	2012-08-18
Prospective Registration:	No
Primary sponsor:	Arak University of Medical Sciences
Public title:	Assessment of efficacy of bispectral monitoring in preventing awareness during anesthesia in pregnant women candidates for elective caesarean section
Scientific title:	Assessing effect of bispectral index monitoring on awareness level during anesthesia in pregnant women candidates for elective caesarean section
Date of first enrolment:	2011-08-18
Target sample size:	2:214;
Recruitment status:	Completed
URL:	http://www.chictr.org.cn/showproj.aspx?proj=7111
Study type:	Interventional study
Study design:	Randomized parallel controlled trial
Phase:	I (Phase I study)

Countries of recruitment
Iran

Contacts

Name:	Nooshin Bagherani
Address:	Khoramshahr
Telephone:	+989188636512
Email:	nooshinbagherani@yahoo.com
Affiliation:	Nooshin Bagherani's office

Name:	Ali Reza Kamali
Address:	Department of Anesthesiology, Arak University of Medical Sciences, Arak, Iran.
Telephone:	+989188632376
Email:	alikamaliir@yahoo.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Age range of 15-45 years;Gestational age between 37 to 42 weeks; ASA score I and II; Duration of the CS less than 1 hour; Duration of the intubation less than 35 seconds; No history of systemic disorders especially chronic blood hypertension; No history of eclampsia; No morbid obesity (BMI>35); No history of psychological disorders;No history of opioid use; The same surgeon for the whole patient.
Exclusion criteria: Age range of 15-45 years;
Gestational age between 37 to 42 weeks;
The ASA score >2;
Duration of the CS more than 1 hour;
Duration of the intubation more than 35 seconds;
History of systemic disorders especially chronic blood hypertension;
History of eclampsia;
Morbid obesity (BMI>35);
History of psychological disorders;
History of opioid use.

Age minimum: 15
Age maximum: 45
Gender: Male

Health Condition(s) or Problem(s) studied

Awareness during anesthesia

Intervention(s)

2:BIS index ;

Primary Outcome(s)

Awareness level;

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Arak university of Medical sciences

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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