Protocol summary

Summary
In pediatric dentistry general anesthesia was recommend after all behavioral management method are failed. Stress, fear and fasting of child during operation can cause change in blood glucose level and sever blood glucose change can cause apnea, syncope and delay in recovery. This study design by randomized non - blind clinical trial and the aim of this study is determine and compare blood glucose change, before operation and anesthesia induction, after anesthesia induction and trachea intubation, after operation and before hospital discharge with intravenous anesthesia by Propofol and inhalation anesthesia by Isofluran in children between 4-6 years old refer to dentistry hospital branch of Isfahan medical University. Children are select for study when in complete health statement and haven’t any surgery operation past year and contraindication for Propofol and Isofluran use. Then parental consent and preoperative fasting instruction is obtained at the same. After refer, children are reassessment for general health and if they haven’t any surgery prevention, the cloths are changed and are sent to operation room. Children are select randomly for Propofol and Isofluran anesthesia groups, then if child haven’t any problem IV line is done, unless they are sedated with 50% N2O, 50% O2 and 5% Isofluran and when they don’t response to vocal irritants IV line done. Anesthesia induction in Isofluran group is achieved with Sodium thiopental 6mg/kg, Fentanyl 1µg/kg and Atracurium 0.8mg/kg, in Propofol group is performed with Propofol 2.5-3.5 mg/kg, Fentanyl 1µg/kg and Atracurium 0.8mg/kg. Anesthesia maintenance in Isofluran group is performed with 50% N2O, 50% O2 and 1.5% Isofluran and in Propofol group is achieved with 50% N2O, 50% O2 and 9mg/kg/hr Propofol. After finger disinfection blood glucose assessment is perform with drop of blood by glucometer (Accu-chek), before operation and anesthesia induction, after anesthesia induction and trachea intubation, after operation and before hospital discharge.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109034224N17
Registration date: 2012-04-07, 1391/01/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-07, 1391/01/19
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad Khorasgan University of medical sciences, Dental College.
Expected recruitment start date
2011-02-04, 1389/11/15
Expected recruitment end date
2011-11-06, 1390/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial in comparison between Propofol and Isofluran in blood glucose change in general anesthesia in child between 4-6 years old
Public title
Comparison blood glucose change in intravenous anesthesia with Propofol and inhalation anesthesia with Isofluran in child between 4-6 years old that candidate for dental procedure in general anesthesia.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: children between 4-6 years old; parental consent; complete general health consideration; no history of surgery within a year; no contraindication in Isofluran and Propofol use. Exclusion criteria: medical problem during anesthesia.
Age
From 4 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad Khorasgan University, College of dentistry
Street address
College of dentistry, Islamic Azad University khorasgan branch, university Blvd, Arghavaniyeh, eastern jey
City
Khorasgan
Postal code
158-81595
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
77

Health conditions studied

1

Description of health condition studied
blood glucose change
ICD-10 code
E16.0
ICD-10 code description
Hypoglycemia (spontaneous) - drug- induced

Primary outcomes

1

Description
Blood glucose
Timepoint
pre operative before anesthesia induction, post anesthetic induction and trachea intubation and post operative before hospital discharge
Method of measurement
glucometer (Accu-chek)

Secondary outcomes

empty

Intervention groups

1

Description
Blood glucose measurement during general anesthesia in Propofol group with Propofol 2.5-3.5 mg/kg, Fentanyl 1µg/kg and Atracurium 0.8mg/kg.
Category
Diagnosis

2

Description
Blood glucose measurement during general anesthesia in Isofluran group with Sodium thiopental 6mg/kg, Fentanyl 1µg/kg and Atracurium 0.8mg/kg.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Medical University, Isfahan Dental College.
Full name of responsible person
Dr Naser Kaviani
Street address
Dental academy, University of Medical Sciences, Darvazeh Shiraz square, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research of Dental College- Islamic Azad University of Khorasgan
Full name of responsible person
Dr Vahid Esfahanian
Street address
Islamic Azad University khorasgan branch, university Blvd, Arghavaniyeh, eastern jey
City
Khorasgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research of Dental College- Islamic Azad University of Khorasgan
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Dental College- Isfahan Medical University
Full name of responsible person
Dr Naser Kaviani
Position
Doctor of Anesthesia
Other areas of specialty/work
Street address
Dental academy, University of Medical Sciences, Darvazeh Shiraz square, Isfahan
City
Isfahan
Postal code
73461-8174
Phone
+98 31 1792 2858
Fax
Email
Kaviani@dnt.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
College of dentistry, Islamic Azad University of Khorasgan branch
Full name of responsible person
Hajar Mohebi niya
Position
Student of dentistry
Other areas of specialty/work
Street address
College of dentistry, Islamic Azad University khorasgan branch, university Blvd, Arghavaniyeh, eastern jey
City
Isfahan
Postal code
81595-158
Phone
Fax
Email
moheby14@yahoo.com
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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