Comparative study of the effect of using three anesthesia methods with propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years undergoing fiber optic bronchoscopy.
Determining and comparing the use of three anesthesia methods with propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years undergoing fiber optic bronchoscopy
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 120 patients
Settings and conduct
In this double-blind randomized clinical trial study, 120 eligible children referred to Imam Hossein Hospital in Isfahan will be included in the study and will be randomly divided into three groups. Patients are given propofol, sevoflurane, and dexmedetomidine, respectively. The intervention will be carried out in such a way that the patient, the researcher and the statistical analyst will not have any knowledge of the type of intervention. Then the hemodynamic parameters and complications of the patients will be evaluated and compared among the three groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include children from 1 month to 3 years old, candidates for diagnostic fiberoptic bronchoscopy, with ASA equal to I or II, and consent to participate in the study.
Exclusion criteria include comorbidity and bronchoscopy therapy.
Intervention groups
The first intervention group: patients in this group are under anesthesia with inhaled sevoflurane.
The second intervention group: patients in this group underwent induction of anesthesia with 1 mg/kg propofol and then they were given propofol at a dose of 0.6 mg/kg/h as anesthesia maintenance.
The third intervention group: patients in this group underwent induction of anesthesia with dexmedetomidine at a dose of 1µg/kg, and dexmedetomidine at a dose of 1µg/kg/h is used as anesthesia maintenance.
Comparative study of the effect of using three anesthesia methods with propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years undergoing fiber optic bronchoscopy.
Public title
The effect of using three anesthesia methods with propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years undergoing fiber optic bronchoscopy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 1 month to 3 years
Candidate for diagnostic fiber optic bronchoscopy
ASA equal to I or II
Consent to participate in the study
Exclusion criteria:
Having comorbidity (Such as heart disease, metabolic disease, history of seizures, high ICP, porphyria, thyroid disease)
Therapeutic bronchoscopy (presence of foreign body, etc.)
Age
From 1 month old to 3 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 120 eligible children are randomly selected. For this, the letter A is written on 40 sheets, the letter B is written on 40 sheets, the letter C is written on 40 sheets, and each of them is placed in an envelope. Each Parents of patients is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to achieve the triple-blind study, three drugs, propofol, sevoflurane, and dexmedetomidine will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.MUI.MED.REC.1402.043
Health conditions studied
1
Description of health condition studied
Fiber optic bronchoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure
Timepoint
upon entering the operating room, and every 5 minutes during bronchoscopy and every 15 minutes during recovery until the end of recovery
Method of measurement
Monitoring device
2
Description
Heart beat
Timepoint
upon entering the operating room, and every 5 minutes during bronchoscopy and every 15 minutes during recovery until the end of recovery
Method of measurement
Monitoring device
3
Description
Oxygen saturation (SpO2)
Timepoint
upon entering the operating room, and every 5 minutes during bronchoscopy and every 15 minutes during recovery until the end of recovery
Method of measurement
Monitoring device
4
Description
Respiratory complications
Timepoint
During bronchoscopy
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: patients in this group are under anesthesia with inhaled sevoflurane. In this way, they are first induced with 2 MAC and after deepening the anesthesia, they receive 3.3% sevoflurane(equivalent to 1 MAC) as an anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure.
Category
Treatment - Drugs
2
Description
Second intervention group: patients in this group underwent induction of anesthesia with 1 mg/kg propofol and then they were given propofol at a dose of 0.6 mg/kg/h as anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure.
Category
Treatment - Drugs
3
Description
Third intervention group: patients in this group underwent induction of anesthesia with dexmedetomidine at a dose of 1µg/kg, and dexmedetomidine at a dose of 1µg/kg/h is used as anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Isfahan
Full name of responsible person
Amir Shafa
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Imam Hossein Hospital; Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Imam Hossein Hospital; Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD