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Comparison of the incidence of rigid bronchoscopy complications with three anesthesia methods of spontaneous ventilation, controlled ventilation using Atracurium and controlled ventilation using Rocuronium in children with foreign body aspiration

Protocol summary

Study aim
Comparison of the incidence of rigid bronchoscopy complications with three anesthesia methods of spontaneous ventilation, controlled ventilation using Atracurium and controlled ventilation using Rocuronium in children with foreign body aspiration
Design
A parallel-group, double-blind, randomized (permutation blocks), phase 3 clinical trial on 63 children with foreign body aspiration, using the website www.sealedenvelope.com for randomization.
Settings and conduct
This study is conducted in Ali Asghar Children's Hospital. Children with foreign body aspiration are randomly assigned to 3 groups. The first group is removed by the method of maintaining spontaneous breathing, the second group by the method of controlled breathing with Atracurium, and the third group by the method of controlled breathing with Aocuronium. In this study, children do not know the type of treatment method.
Participants/Inclusion and exclusion criteria
Parents' consent to participate in the study after bronchoscopy, Age range 1 to 6 years, Children with foreign body aspiration , if the foreign body is not in the upper part of the main airway and in the larynx or hypopharynx, They should be in ASA class 1 and 2
Intervention groups
After induction of inhalation anesthesia with Sevoflurane in all three groups, in group P, Propofol infusion is started at a dose of 80-100 mcg/kg/min, and the relaxant drug is not injected, and after 3 minutes, hard bronchoscopy is started. to be In group R, 0.3 mg/kg of rocuronium is injected and bronchoscopy is started after 3 minutes, In group A, 0.3 mg/kg of Atracurium is injected, and after 3 minutes, bronchoscopy is started. Propofol infusion is not performed in group R and A.
Main outcome variables
Laryngospasm

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230506058100N1
Registration date: 2023-06-14, 1402/03/24
Registration timing: registered_while_recruiting

Last update: 2023-06-14, 1402/03/24
Update count: 0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
Tahereh Chavoshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
chavoshi.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the incidence of rigid bronchoscopy complications with three anesthesia methods of spontaneous ventilation, controlled ventilation using Atracurium and controlled ventilation using Rocuronium in children with foreign body aspiration
Public title
The incidence of rigid bronchoscopy complications in children with foreign body aspiration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parents' consent to participate in the study after bronchoscopy Age range 1 to 6 years Children with foreign body aspiration , if the foreign body is not in the upper part of the main airway and in the larynx or hypopharynx They should be in ASA class 1 and 2
Exclusion criteria:
Emergency cases Children with asthma and irritable airways Airway anomaly Drug allergy to any of the drugs used Neurological disorders and seizures kidney disease Cardiovascular disease Neuromuscular disorder Metabolic disorder
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method with block size 4 is used. The website https://www.sealedenvelope.com is used to generate random sequences. Each of the randomly generated sequences contains a unique code for concealment. The randomized list is provided to one of the operating room personnel and he tells the researcher which group each patient should be placed in. Then the patients are assigned to 3 groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient blinding: Patients are unaware of the treatment process due to their condition and they are unconscious. Care giver blinding: in 3 groups, Propofol will be drawn into a syringe and connected to the infusion pump, but it will be injected only in the Propofol group. Propofol is distilled water, and in Rocuronium and Atracurium groups, the dose of the corresponding drug is the same, so it is not possible for the assistant data recorder and the person performing the bronchoscopy to distinguish the Propofol group from the other two groups.
Placebo
Not 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
Iran University of Medical Sciences; Next to the Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.IUMS.FMD.REC.1402.026

Health conditions studied

1

Description of health condition studied
Foreign body aspiration
ICD-10 code
T17.9
ICD-10 code description
Foreign body in respiratory tract, part unspecified

Primary outcomes

1

Description
Laryngospasm
Timepoint
beginning of bronchoscopy to end of anesthesia and the patient waking up
Method of measurement
Decreased oxygen saturation following epiglottis closure

Secondary outcomes

empty

Intervention groups

1

Description
Group P or Propofol : After induction of inhalation anesthesia with Sevoflurane, Propofol infusion is started at a dose of 80-100 mcg/kg/min, and the relaxant drug will not be injected, and after 3 minutes, rigid bronchoscopy is started. In this group, assisted breathing is given by controlling the ambobag and chest movements, and after the procedure, the drugs are removed.
Category
Treatment - Surgery

2

Description
Group R or Rocuronium: after induction of inhalation anesthesia with Sevoflurane, Rocuronium is injected at a dose of 0.3 mg/kg and bronchoscopy is started after 3 minutes, Propofol infusion is not performed in this group, and the oxygen line is connected through an interface next to the bronchoscope (T segment), and controlled breathing is given with an ambobag through the Mepleson D system. If the procedure is prolonged, and need to repeat the relaxant Rocuronium is prescribed at a dose of 0.2 mg /kg and 0.3 mg /kg. After the procedure, breathing with a face mask and oxygen and low dose Sevoflurane (1%) continues until the patient's breathing returns, and then Sevoflurane is stopped and reversed with Atropine 0.02 mg /kg and Neostigmine 0.05 mg/kg.
Category
Treatment - Surgery

3

Description
Group A or Atracurium: after induction of inhalation anesthesia with Sevoflurane, Atracurium is injected at a dose of 0.3 mg/kg and after 3 minutes' bronchoscopy is started. Propofol infusion is not performed in this group, and the oxygen line is connected through an interface next to the bronchoscope (T segment), and controlled breathing is given with an ambobag through the Mepleson D system. If the procedure is prolonged need to repeat the relaxant drug, Atracurium is prescribed at a dose of 0.2 and 0.3 mg /kg. After the procedure, breathing with a face mask and oxygen and low dose Sevoflurane (1%) continues until the patient's breathing returns, and then Sevoflurane is stopped and reversed with Atropine 0.02 mg /kg and neostigmine 0.05 mg/kg is done.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliasghar Children's Hospital
Full name of responsible person
Tahereh Chavoshi
Street address
No.193, Zafar St, Modares Highway,
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
chavoshi.t@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Next to the Milad tower; Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Tahereh Chavoshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.193, Zafar st, Moddares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
Chavoshi.t@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Chavoshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.193, Zafar st, Moddares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
Chavoshi.t@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Chavoshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.193, Zafar st, Moddares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
Chavoshi.t@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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