Protocol summary

Study aim
Comparative study of using laryngeal mask (LMA) with and without muscle relaxant in anesthesia of children one to four years old undergoing upper extremity reconstructive surgery
Design
This study is a double-blind, randomized, phase 3 clinical trial on 70 patients and block randomization method will be used.
Settings and conduct
After proper and standard monitoring, we establish a suitable intravenous injection route from the patient and in two groups of patients, general anesthesia is performed according to the necessary standards (drug injection and anesthesia method). In the first group, neuromuscular relaxant is used as an intervention during induction and the appropriate size of laryngeal mask is selected according to the patient's weight. In the second group, normal saline is used instead of neuromuscular relaxant. According to the patient's weight, the appropriate size of laryngeal mask is selected, then the objectives of the study are compared in two groups. This study is performed in Hazrat Fatemeh Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children one to four years old, anesthesia score ASA 1, 2, upper limb injury Exclusion criteria: Children with the possibility of difficult intubation, Children with upper airway infections, Children with congenital diseases with unusual airway, Children with a history of seizures and neurological diseases, Children at high risk for pulmonary aspiration.
Intervention groups
In one group of patients, neuromuscular relaxant is used as an intervention during induction of anesthesia, and in another group, normal saline is used instead of neuromuscular relaxant.
Main outcome variables
Laryngeal mask placement, intraoperative movement of laryngeal mask, laryngeal mask pressure, laryngeal mask complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110513006465N3
Registration date: 2021-06-15, 1400/03/25
Registration timing: prospective

Last update: 2021-06-15, 1400/03/25
Update count: 0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Seyed Alireza Seyed Siamdoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 1749
Email address
siamdoust.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of using laryngeal mask (LMA) with and without muscle relaxant in anesthesia of children one to four years old undergoing upper extremity reconstructive surgery in Hazrat Fatemeh Hospital.
Public title
Comparison of the use of laryngeal mask with and without muscle relaxant in anesthesia of children one to four years old.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children one to four years old Anesthesia score ASA 1, 2 Upper limb injury
Exclusion criteria:
Children with the possibility of difficult intubation Children with upper airway infections Children with congenital diseases with unusual airway Children with a history of seizures and neurological diseases Children at high risk for pulmonary aspiration
Age
From 1 year old to 4 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the person evaluating the goals are unaware of the type of intervention being assigned.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2021-01-03, 1399/10/14
Ethics committee reference number
IR.IUMS.FMD.REC.1399.550

Health conditions studied

1

Description of health condition studied
Children's diseases
ICD-10 code
Y81
ICD-10 code description
General- and plastic-surgery devices associated with adverse incidents

Primary outcomes

1

Description
Laryngeal mask placement
Timepoint
During anesthesia
Method of measurement
Using a three-point rating table

2

Description
Movement during laryngeal mask surgery
Timepoint
During anesthesia
Method of measurement
View by the anesthesiologist and the opinion of the anesthesia assistant

Secondary outcomes

1

Description
Laryngeal mask pressure
Timepoint
During anesthesia
Method of measurement
By barometer

2

Description
Complications of laryngeal mask
Timepoint
By barometer
Method of measurement
By observation and recording by the researcher

Intervention groups

1

Description
Intervention group: In one group of patients, the neuromuscular relaxant drug Atracurium made by Caspian Pharmaceutical Company at a dose of 0.5 mg / kg is used as an intervention during induction of anesthesia. The drug is drawn in a 5 cc syringe and labeled A.
Category
Treatment - Drugs

2

Description
Control group: In the other group, instead of using a neuromuscular relaxant, normal saline is used. The drug is drawn in a 5 cc syringe and labeled B.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat fatemeh hospital
Full name of responsible person
Seyed alireza seyed siamdoust
Street address
21th Str. Asadabadi Ave. Hazrate Fatemeh Hospital
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8871 7272
Email
siamdoust.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed abbas Motavalian
Street address
21th Str. Asadabadi Ave. Hazrate Fatemeh Hospital
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyed alireza seyed siamdoust
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
21th Str. Asadabadi Ave. Hazrate Fatemeh Hospital
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8877 1749
Email
siamdoust.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed alireza seyed siamdoust
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
21th Str. Asadabadi Ave. Hazrate Fatemeh Hospital
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8877 1749
Email
siamdoust.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed alireza seyed siamdoust
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
21th Str. Asadabadi Ave. Hazrate Fatemeh Hospital
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8877 1749
Email
siamdoust.a@iums.ac.ir

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
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