Determination of Bispectoral index scores of patients under dental treatment in children between 4-7 years old assigned for general anesthesia under Propofol and Isofloran regimes.
The aim ofthis study is supportive care service by assessment the correlation of Bispectoral index scores of patients under dental treatment in children assigned for general anesthesia under Propofol and Isofloran regimes. Inclusion Criteria: Systemic Condition: ASAI, ASAII; Uncooperative children dentistry operation candidate for general anaesthesia; children between 4-7 years old; Exclusion Criteria: Exist of Hypoxia; Arrhythmia; Pain in recovery room; Agitation; Nausea;The time of general anesthesia less than 60 or more than 90 minutes; Using sedate or sedation drug by the children interfering. In this study 32 healthy children between 4-7 years that they candidate for treatment of dentistry are divided in to two groups at random .In both BIS device will use.Bispectral index (BIS) is one of several technologies which purport to monitor depth of anesthesia. The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS score between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturerIn group 1 general anesthesia will maintain by intravenous Propofol and in group 2 by inhaletion of Isofloran 1%.BIS score is recorded for each child evey 10 minute scince general anesthesia onsets.After gathering sampels datas will be analyzed with pairt-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013032212848N1
Registration date:2013-06-25, 1392/04/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-25, 1392/04/04
Registrant information
Name
Dana Tahririan
Name of organization / entity
Dental college, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1673 2985
Email address
tahririan@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of Bispectoral index scores of patients under dental treatment in children between 4-7 years old assigned for general anesthesia under Propofol and Isofloran regimes.
Public title
Brain activity during general anesthesia and recovery conditions under tow general anesthesia regimes.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: Systemic Condition: ASAI, ASAII; Uncooperative children dentistry operation candidate for general anaesthesia; children between 4-7 years old; Exclusion Criteria: Exist of Hypoxia; Arrhythmia; Pain in recovery room; Agitation; Nausea;The time of general anesthesia less than 60 or more than 90 minutes; Using sedate or sedation drug by the children interfering.
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Dental College, Isfahan University of Medical Sciences
Street address
Isfahan Dental College, Isfahan University of Medical Sciences, HezarJarib Street, Isfahan
City
Isfahan
Postal code
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
391468
Health conditions studied
1
Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F93.8
ICD-10 code description
Other childhood emotional disorder
2
Description of health condition studied
recovery conditions
ICD-10 code
f10,f11,f1
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Consciousness and brain activity which can be read through the BIS device connected to the patient.
Timepoint
Every ten minute as general anesthesia begins, by a By technician unaware of the topic of the study.
Method of measurement
By recording from the BIS device
Secondary outcomes
1
Description
Agitation in recovery room.
Timepoint
Every ten minute in recovery room by an unaware(topic of strudy and used regime) technician
Method of measurement
Sikich- lerman index
Intervention groups
1
Description
intervention:intravenous propofol100 μg/Kg/min for maintainance dose.
Category
Prevention
2
Description
intervention:isoflorane1% for maintainance dose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Aminallah Tavangar
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences, Shohadaye Sofe Street
City
Isfahan
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, Isfahan 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
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Dana Tahririan
Position
Specializes Asisitant
Other areas of specialty/work
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar jarib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2891
Fax
Email
dana_tahririan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Dana Tahririan
Position
Specialized Asistant, DDs
Other areas of specialty/work
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar jarib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2891
Fax
Email
dana_tahririan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Dana Tahririan
Position
Specialized Asistant
Other areas of specialty/work
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar jarib street, Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
dana_tahririan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)