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The effect of Bispectral index Monitoring on recovery from anesthesia and early postanesthetic complication after cesarean section

Protocol summary

Summary
This randomized clinical trials , dubel-blind study aims to investigate the effects of aesthesia depth monitoring on the recovery and post-operative complications of cesarean candidates in the ward and recovery on 68 patients in the case and control groups who have inclusion criteria during 4 months will be down. In both groups, the beginning of anesthesia is similar; however, infusion of anesthetic drug is with Bispectral Index (BIS) in the case group and by the conventional routine in the control group. At the end of surjery, anesthetic drugs will be stopped, and the time of extubation, recovery time, nausea, vomiting, shivering, and agitation in the recovery, and 6 hours after operation will be compared. Moreover, awareness during operation will be assessed 24 hours after the operation by a questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080218643N1
Registration date: 2014-11-28, 1393/09/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Rajab Arbabpour
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3231 6829
Email address
arbabpor@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Bispectral index Monitoring on recovery from anesthesia and early postanesthetic complication after cesarean section
Public title
Effects of aesthesia deep monitoring on the recovery of cesarean candidates
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Natural pregnancy; 20-35 years of age; Elective cesarean; No drug use 48 hours before operation, except for iron, folic acid, and multi-vitamins; No history of diabetes, pre-eclampsia, eclampsia, hyperthyroidism, hypothyroidism, heart and renal problem, asthma, mental and psychological disorders, and addiction. Exclusion criteria: cesarean section duration over 45 min; Need for changes anesthesia method; Emergency situation for the mother or child; Suspect of the indicated depth according to the physician in the intervention group, and thus change in anesthesia method
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari St., Birjand, Sothern Khorasan
City
Birjand
Postal code
Approval date
2014-07-05, 1393/04/14
Ethics committee reference number
03-04-1393

Health conditions studied

1

Description of health condition studied
Elective cesarean
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section

Primary outcomes

1

Description
Propofol dose needed for patients
Timepoint
Drug use calculation Immediately after operation
Method of measurement
Based on received drug min/kg

Secondary outcomes

1

Description
Postoperative complication (nausea, vomiting, shivering, and agitation)
Timepoint
During 24 hours after operation for complication
Method of measurement
Questionnaire / interview

Intervention groups

1

Description
Case group: The intervention group dose of anesthesia drug will be regulated in the base of BIS
Category
Other

2

Description
Control group: Controls receive the conventional anesthesia drugs.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-asr Hospital in Birjand
Full name of responsible person
Rajab Arbabpour
Street address
Operating room, Vali-asr Hospital, Ghaffari St., Birjand, Sothern Khorasan
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Rajab Arbabpour
Street address
Vali-asr Hospital, Ghaffari St., Birjand, Sothern Khorasan
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Rajab Arbabpour
Position
Master of Nursing
Other areas of specialty/work
Street address
Vali-asr Hospital, Ghaffari St., Birjand, Sothern Khorasan
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
Email
arbabpor@bums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Ganji
Position
PhD of Anaesthesia
Other areas of specialty/work
Street address
Vali-asr Hospital, Ghaffari St., Birjand, Sothern Khorasan
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
Email
arbabpor@bums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Rajab Arbabpour
Position
Master of Nursing
Other areas of specialty/work
Street address
Operating room, Vali-asr Hospital, Ghaffari St., Birjand, Sothern Khorasan
City
Birjand
Postal code
Phone
+98 56 3244 3001
Fax
Email
arbabpor@bums.ac.ir
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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