Comparison of induction with incremental versus fixed high concentration of sevoflurane in children.
Design
Double-blind clinical trial, randomized, control group, with parallel groups
Settings and conduct
This study will be conducted in the operating room of Tabriz Children's Hospital. Data carers and data analyst will be blinded. Patients will be randomly divided into two groups and intervention will be performed as follows.
The anesthetic system will be filled in with a 30% oxygen mixture and 70% N2O after closing the pop-off and end of the system. Then with mask filled with anesthetic gases, an inhalation with a mask begins. After two minutes of Sevoflurane, 8% is added to the anesthetic gases.
Participants/Inclusion and exclusion criteria
Entry requirements:
ASA Class I and II
Conditions of Exit Study:
Dissatisfied to participate in the study
Intervention groups
Intervention group:
Anesthesia induction with 30% oxygen mixture and 70% N2O will be performed and after two minutes, sevoflurane 8% will be added to the anesthetic gases.
control group:
The anesthetic induction will begin with oxygen and N2O, as in the first group, and after 2 minutes, 1% sevoflurane will be added and 1% after each 2-3 breaths of sevoflurane will be added.
Main outcome variables
Duration of induction of anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N3
Registration date:2019-05-15, 1398/02/25
Registration timing:prospective
Last update:2019-05-15, 1398/02/25
Update count:0
Registration date
2019-05-15, 1398/02/25
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of induction with incremental versus fixed high concentration of sevoflurane in children
Public title
Induction of general anesthesia in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I-II classes
Exclusion criteria:
Dissatisfied to participate in the study
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the individual statistical analyst will not be aware of the type of group intervention during the intervention, and will only receive the information completed by the researcher's assistance outside the operating room.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1093
Health conditions studied
1
Description of health condition studied
Depth of anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of induction of anesthesia
Timepoint
Every five minutes
Method of measurement
Researcher made checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Anesthesia induction is started with oxygen and N2O, and after two minutes, Sevoflurane is added at a concentration of 8% until the eye-lash Reflex is removed. After the disappearance of the eyelid reflex, the concentration of anesthetic gas will be changed to 50% oxygen and 50% N2O and 3% Sevoflurane and continue to increase the anesthetic depth of the anesthetic gas for the insertion of the intravenous catheter at the same concentration.
Category
Prevention
2
Description
Control group: Anesthesia induction is started with oxygen and N2O, and after 2 minutes, 1% of Sevoflurane is added and after 1 to 2 breaths, Sevoflurane is added until the eye-lash refractory. After elimination of the eyelid reflex Concentrate anesthetic gas to 50% oxygen and 50% N2O 3% Sevoflurane and continue to increase the depth of anesthesia for insertion of an IV catheter into anesthetic gases at the same concentration.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Childrens Hospital
Full name of responsible person
Mahin SEyed Hejazi
Street address
Sheshgelan Ave, Childrens Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seyed Hejazi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seyed Hejazi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available