Comparison of depth of anesthesia in patients under general anesthesia with Propofol or Isofluran undergoing total abdominal hysterectomy with bispectral index
Measurement of depth of anesthesia during surgery in different types of anesthesia (volatile and intravenous)in patients who monitored based on hemodynamic changes, is the aim of this study.In this randomised single blind trial, 24 women 35-65 years old with no history of cardiac disease, hypertension, diabetes, renal or hepatic disease, no history of allergy to egg candidate for total abdominal hysterectomy will be chosen.After similar induction of anesthesia, anesthesia will be maintained with volatile anesthetic (Isoflorane) or interavenously (propofol) and resident or technician of anesthesia will be permitted to to increase or decrease dose of anesthetics based on blood pressure changes on a determined protocol. Depth of anesthesia, will be measured at the beginning of anesthesia, after induction and intubation and in minutes 30 and 60 and blood pressure and heart rate wil be recorded too.. Mean of measurements will be compared between two groups and difference in depth of anesthesia and awareness between two groups will be recorded.
General information
Acronym
changes in depth of anesthesia during anesthesia with propofol and isoflurane
IRCT registration information
IRCT registration number:IRCT201112024969N5
Registration date:2012-01-15, 1390/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Tehran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
drpournajafian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of depth of anesthesia in patients under general anesthesia with Propofol or Isofluran undergoing total abdominal hysterectomy with bispectral index
Public title
Comparison of depth of anesthesia in patients under general anesthesia with Propofol or Isoflurane undergoing total abdominal hysterectomy with bispectral index
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:women ASA I,II candidate for total abdominal hysterectomy.
Exclusion criteria: Ages less than 35 and more than 65 years old; history of cardiac disease; hypertension; diabetes; renal or hepatic disease; no history of allergy to egg or propofol in previous anesthesia(if she had); heart rate and blood pressure changes more than 30% of baseline; any vasoactive or vasodilator injection requirement more than expected in protocol.
Age
From 35 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Ghods st. - keshavarz blvd.
City
Tehran
Postal code
Approval date
2011-11-27, 1390/09/06
Ethics committee reference number
1811/130/ص/90
Health conditions studied
1
Description of health condition studied
depth of anesthesia and blood pressure
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
depth of anesthesia
Timepoint
at the beginning of anesthesia,then every 30 minutes
Method of measurement
number from 100, by BIS
2
Description
systolic blood pressure
Timepoint
at the beginning of anesthesia,then every 30 minutes
Method of measurement
automatic
3
Description
diastolic blood pressure
Timepoint
at the beginning of anesthesia,then every 30 minutes
Method of measurement
automatic
4
Description
heart rate
Timepoint
at the beginning of anesthesia,then every 30 minutes
Method of measurement
puls oxymeter
Secondary outcomes
empty
Intervention groups
1
Description
Anesthesia with Isoflorane as 0.6 to 1.4 % of inspiratory gas
Category
Treatment - Other
2
Description
Anesthesia with intravenous Propofol infusion 100 to 200 microgram per kilogram body weight
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Alireza Pournajafian
Street address
Beh Afarin st. Karim Khan blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mrs. Alamdar
Street address
Ghods st. - keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?