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The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane in children

Protocol summary

Study aim
Studying the speed of induction with inhalation anesthesia using sevoflurane with constant percentage but with different amounts of Fresh Gas Flow in children
Design
A randomized, phase 3, single blind, clinical trial with three intervention groups will be performed using the Power and Sample Size software and considering the alpha error of 5% and the study power of 90%, the calculated sample size for each group is 17. It will be the case that with an additional safety margin of about 15%, a total of 60 patients (20 in each group) will be studied. The rand function of Excel software was used for randomization.
Settings and conduct
60 children aged 6 months to 8 years and with ASA class I and II whom are candidates for elective orthopedic surgeries will be studied in 3 separate groups at Shohada Hospital in Tabriz. After obtaining informed consent from the parents, they will be randomly placed in three separate groups A, B, and C, which are defined based on the amount of FGF during inhalation induction. Calibrated will be done. Only the patient is blind to the medicine received.
Participants/Inclusion and exclusion criteria
Age between 6 month to 8 years old Candidate for elective orthopedic surgery Having an indication for inhalational induction of anesthesia
Intervention groups
Three groups named A, B and C will be arranged based on the amount of fresh gas flow, Consisting of group A = 2 L/min, group B = 4 L/min, group C = 6 L/min. In all three groups, a fixed output percentage of sevoflurane (8%) will be used for induction of anesthesia.
Main outcome variables
Duration of reaching to the Bispectral Index between 60 to 70 Duration till the loss of response to squeezing the trapezius muscle Duration until Laryngeal Mask Airway installation Existence of reaction to Laryngeal Mask Airway installation Heart rate Blood pressure Oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220301054154N1
Registration date: 2022-09-20, 1401/06/29
Registration timing: retrospective

Last update: 2022-09-20, 1401/06/29
Update count: 0
Registration date
2022-09-20, 1401/06/29
Registrant information
Name
Elham sadat Tabatabaeenezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 4813
Email address
tabatabaeenezhadelham@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane in children
Public title
The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 month to 8 years candidate for elective orthopedic surgery having an indication for inhalational induction of anesthesia
Exclusion criteria:
lack of parental consent emergent surgery not being NPO significant cardiovascular disease pulmonary disease neurologic disorder prediction of a difficult airway or IV line facial or airway anomalies history of malignant hyperthermia in the patient or their family acute respiratory infection in the past week history of GERD
Age
From 6 months old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Through a randomly generated computer-generated list, individuals will be assigned to three intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research only the patient is unaware of the fresh gas flow.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National committee for ethics in biomedical research (Tabriz university of medical sciences)
Street address
Faculty of medicine, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
IR.TBZMED.REC.1400.557

Health conditions studied

1

Description of health condition studied
The effect of Fresh Gas Flow on the speed of inhalational induction with sevoflurane
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
duration of reaching to the Bispectral Index between 60 to 70
Timepoint
from the start point of induction untill reaching to the Bispectral Index between 60 to 70
Method of measurement
using the bispectral index monitor based on electroencephalogram waves during anesthesia, measuring time in seconds

2

Description
duration till the loss of response to squeezing the trapezius muscle
Timepoint
from the start point of induction to complete loss of response to squeezing the trapezius muscle
Method of measurement
measuring time in seconds, by physical examination and observing patient's reaction

3

Description
Duration until Laryngeal Mask Airway installation
Timepoint
from the start point of induction until Laryngeal Mask Airway installation
Method of measurement
measuring time in seconds

4

Description
Existence of reaction to Laryngeal Mask Airway installation
Timepoint
During Laryngeal Mask Airway insertion
Method of measurement
Observing the patient's reaction

5

Description
heart rate
Timepoint
Immediately before induction and one minute after induction and during operation of the Laryngeal Mask Airway
Method of measurement
Beat Per minute using a non-invasive heart rate monitor

6

Description
Blood pressure
Timepoint
Immediately before induction and one minute after induction and during operation of the Laryngeal Mask Airway
Method of measurement
In millimeters of mercury using a non-invasive method of measuring blood pressure by monitoring device.

7

Description
Oxygen saturation
Timepoint
Immediately before induction and one minute after induction and during operation of the Laryngeal Mask Airway
Method of measurement
in percent, by pulse oximeter device

Secondary outcomes

1

Description
Breath holding
Timepoint
From the beginning of induction to the end of anesthesia
Method of measurement
observation

2

Description
coughing
Timepoint
From the beginning of induction to the end of anesthesia
Method of measurement
observation

3

Description
bradycardia
Timepoint
From the beginning of induction to the end of anesthesia
Method of measurement
Beat Per minute using a non-invasive heart rate monitor

4

Description
low Blood pressure
Timepoint
From the beginning of induction to the end of anesthesia
Method of measurement
In millimeters of mercury using a non-invasive method of measuring blood pressure by device.

5

Description
laryngospasm
Timepoint
From the beginning of induction to the end of anesthesia
Method of measurement
observation

6

Description
vomiting
Timepoint
From the beginning of induction to the end of anesthesia
Method of measurement
observation

Intervention groups

1

Description
Intervention group: A with FGF of 2 L/min
Category
Treatment - Drugs

2

Description
Intervention group: B with FGF of 4 L/min
Category
Treatment - Devices

3

Description
Intervention group: C with FGF of 6 L/min
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Dr. Masoud Parish
Street address
Shohada Hospital, Golshahr street, El Goli Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3336
Email
parishm@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Research Vice-Chancellor, Third floor, the headquarter building No 2, Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Masoud Parish
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Gholshahr Avenue, Yaghchian street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3385 5842
Email
parishm@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Golshahr Avenue, Yaghchian street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
009833855842
Email
parishm@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Gholshahr Avenue, Yaghchian street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
009833855842
Email
parishm@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academia and people in industry.
Under which criteria data/document could be used
There are no specific restrictions on the use of data or documentation.
From where data/document is obtainable
Dr .Masoud Parish Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran oudparish@yahoo.com Phone: +98 413 3341994
What processes are involved for a request to access data/document
Applicants will have access to the data from the present study by sending an email to the responsible author for a maximum of one week.
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