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The effect of laryngotracheal anesthesia with McKenzie method for the ease of pediatric rigid bronchoscopy.

Protocol summary

Study aim
Checking the effects of laryngotracheal anesthesia on the ease of bronchoscopy in children.
Design
Clinical trial with intervention and control groups, with parallel groups, double-blind, randomized, sample of 64 patients. Randlist software was used for randomization.
Settings and conduct
All patients candidate for pediatric bronchoscopy and undergoing laryngotracheal anesthesia at Tabriz pediatric Hospital will be included in this study. Patients are randomly assigned to two intervention and control groups.In intervention group, lidocaine and in control group, normal saline will be used to compare the effects of McKenzie's laryngotracheal anesthesia on rigid bronchoscopy in children. In this study, the patient and anesthesiologist are blinded to study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All children under the age of seven, With ASA grade,class I&II , Candidate for rigid bronchoscopy, Exclusion criteria: Head and neck anomalies, Feverish patients, Children with airway anomalies, Children with underlying disease.
Intervention groups
Intervention group:In this group after induction and laryngoscopy, the blend of lidocaine 2%(Caspian Taamin pharmaceutical company)0.3milliliter per kilogram with oxygen in the laryngotracheal area will be flashed by the McKenzie method(A kind of anesthesia method). Control group:In this group,0.3 milliliter per kilogram normal saline 0.9% (Saamen pharmaceutical company )with oxygen in the laryngotracheal region,will be flashed by McKenzie method(A kind of anesthesia method).
Main outcome variables
Ease of bronchoscopy, blood pressure , heart rate, oxygen saturation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100527004041N21
Registration date: 2020-05-22, 1399/03/02
Registration timing: registered_while_recruiting

Last update: 2020-05-22, 1399/03/02
Update count: 0
Registration date
2020-05-22, 1399/03/02
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of laryngotracheal anesthesia with McKenzie method for the ease of pediatric rigid bronchoscopy.
Public title
The effect of laryngotracheal anesthesia for pediatric bronchoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children under the age of seven With ASA grade,class I&II and Candidate for rigid bronchoscopy
Exclusion criteria:
Head and neck anomalies Feverish patients Children with airway anomalies Children with underlying disease
Age
From 1 day old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software and blocks of size two.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the thesis owner student provides the drugs to the anesthesiologist and is the only person who is not blind to the study.The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner.So that anesthesiologist is unaware of the injected drug to patient during injection.The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills in the checklist during surgery and recovery.The patient is also unaware of the type of Injecting drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.TBZMED.REC.1399.045

Health conditions studied

1

Description of health condition studied
Pediatric bronchoscopy
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Ease of bronchoscopy
Timepoint
Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes.
Method of measurement
Based on the surgeon's consent, scoring as: Easy (0) - Medium (1) - Hard (2)

2

Description
Systolic and diastolic blood pressure
Timepoint
Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes.
Method of measurement
Mercury barometer

3

Description
Heart rate
Timepoint
Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes.
Method of measurement
Counting in each minutes

4

Description
Saturation of peripheral oxygen
Timepoint
Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes.
Method of measurement
Via the Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In this group after induction and laryngoscopy, the blend of lidocaine 2%(Caspian Taamin pharmaceutical company)0.3milliliter per kilogram with oxygen in the laryngotracheal area will be flashed by the McKenzie method(A kind of anesthesia method).
Category
Treatment - Drugs

2

Description
Control group:In this group,0.3 milliliter per kilogram normal saline 0.9% (Saamen pharmaceutical company )with oxygen in the laryngotracheal region,will be flashed by McKenzie method(A kind of anesthesia method).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating room, Tabriz Children Hospital
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Tabriz pediatric hospital,sheshgelan street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2279
Email
kodakanhospital@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+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
Dr. Mahin Seyedhejazi
Position
Anesthesiologist/Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz pediatric hospital,sheshgelan street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2255
Email
seidhejazie@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Anesthesiologist/Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz pediatric hospital,sheshgelan street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2255
Email
seidhejazie@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Anesthesiologist/Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz pediatric hospital,sheshgelan street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2255
Email
seidhejazie@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
Starting 6 months after publication .
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Mahin Seyedhejazi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , seidhejazie@tbzmed.ac.ir
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.
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