Comparison of the prevalence of respiratory complications in two methods of anesthesia with endotracheal intubation and without endotracheal intubation in children under two years old candidate for endoscopy
Comparison of anesthesia with intubation and non intubation technique in children under two years of age, candidates for endoscopy, referred to Mofid hospital
Design
Randomized clinical trail with control group. Randomization with blocking method. Sample size of 120 patients (60 in each group).
Settings and conduct
All patients under two years old referred to the endoscopic ward of Mofid children's hospital. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA Class I,II patients; under 2 years ;admitted or outpatient. Non-inclusion criteria: Emergent patients; ASA Class III and higher.
Intervention groups
Intervention group 1: sedated without tracheal intubation
Intervention group 2: anesthetized with tracheal intubation
Comparison of the prevalence of respiratory complications in two methods of anesthesia with endotracheal intubation and without endotracheal intubation in children under two years old candidate for endoscopy
Public title
The prevalence of respiratory complications in two methods of anesthesia with endotracheal intubation and without endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in ASA Class I & II
Admitted outpatient or inpatient
Exclusion criteria:
Emergent patients
ASA Class III and higher
Age
From 1 day old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the balance in the two groups, the block randomization method is used, which is a limited randomization method. The first step is to create a random sequence. In the second step, the blocks we created are concealed and then in the execution stage, the blocks are assigned. The number of the blocks is 8 (4 blocks for each group)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Mofid Children's Hospital; Shariati Street
City
Tehran
Province
Tehran
Postal code
15468-15514
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.257
Health conditions studied
1
Description of health condition studied
Children under two years of age who present with gastrointestinal symptoms and are candidates for endoscopy under the diagnosis of a pediatric gastroenterologist
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
O2 saturation
Timepoint
Duration of endoscopy until the end of recovery and discharge from the endoscopy unit
Method of measurement
questionnaire
2
Description
Respiratory rate
Timepoint
Duration of endoscopy until the end of recovery and discharge from the endoscopy unit
Method of measurement
questionnaire
3
Description
Heart rate
Timepoint
Duration of endoscopy until the end of recovery and discharge from the endoscopy unit
Method of measurement
questionnaire
4
Description
Blood pressure
Timepoint
Duration of endoscopy until the end of recovery and discharge from the endoscopy unit
Method of measurement
questionnaire
5
Description
ECG changes
Timepoint
Duration of endoscopy until the end of recovery and discharge from the endoscopy unit
Method of measurement
questionnaire
6
Description
Duration of anesthesia
Timepoint
time from starting the anesthesia to patient awakening
Method of measurement
questionnaire
7
Description
Duration of endoscopy
Timepoint
From the beginning of the endoscopy to the exit of the endoscope from the patient's mouth
Method of measurement
questionnaire
8
Description
laryngospasm complication during anesthesia
Timepoint
From the beginning of anesthesia to the end of anesthesia
Method of measurement
questionnaire
9
Description
bronchospasm complication during anesthesia
Timepoint
From the beginning of anesthesia to the end of anesthesia
Method of measurement
questionnaire
10
Description
patient movement during anesthesia
Timepoint
From the beginning of anesthesia to the end of anesthesia
Method of measurement
questionnaire
11
Description
bucking and coughing during anesthesia
Timepoint
From the beginning of anesthesia to the end of anesthesia
Method of measurement
questionnaire
12
Description
nausea and vomiting
Timepoint
From the start of anesthesia to discharge from recovery
Method of measurement
questionnaire
13
Description
seizure
Timepoint
From the start of anesthesia to discharge from recovery
Method of measurement
questionnaire
14
Description
apnea
Timepoint
From the start of anesthesia to discharge from recovery
Method of measurement
questionnaire
15
Description
salivation
Timepoint
From the start of anesthesia to discharge from recovery
Method of measurement
questionnaire
16
Description
bleeding after endoscopy
Timepoint
From the start of endoscopy to discharge from recovery
Method of measurement
questionnaire
17
Description
gastric / esophageal perforation after endoscopy
Timepoint
From the start of endoscopy to discharge from recovery
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: sedation without tracheal intubation, after confirming adequate fasting (6 hours for foods and milk, 4 hours for breast milk, 2 hours for clear liquids) if they are over 6 months old, Midazolam is given at the dose of 0.05 mg per kilogram of body weight. Then Ketamine is injected at the dose of 1 mg per kilogram. Sedation is continued with repeated doses of Propofol at 0.3 to 1 mg per kilogram during endoscopy. Depending on the anesthesiologist's diagnosis and to increase the depth of anesthesia and sedation, patients receive Fentanyl at the dose of 1 microgram per kilogram of body weight.
Category
Treatment - Devices
2
Description
Intervention group: sedation with tracheal intubation , after confirming adequate fasting (6 hours for foods and milk, 4 hours for breast milk, 2 hours for clear liquids) if they are over 6 months old, Midazolam is given at the dose of 0.05 mg per kilogram of body weight. Then Ketamine is injected at the dose of 1 mg per kilograms. After injecting Propofol with the dose of 1.5-2 mg per kilogram and ensuring adequate apnea and relaxation, intubation is performed with a suitable size tube. Sedation is continued with repeated doses of Propofol at 0.3 to 1 mg per kilogram during endoscopy. Depending on the anesthesiologist's diagnosis and to increase the depth of anesthesia and sedation, patients receive Fentanyl at the dose of 1 microgram per kilogram of body weight.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's hospital
Full name of responsible person
Nastaransadat Mahdavi
Street address
Mofid children's hospital; Shariati street
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7021
Email
nasimahdavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Velenjak street; Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
90
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaransadat Mahdavi
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid children's hospital; Shariati street
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2225 0680
Email
nasimahdavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaransadat Mahdavi
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid children's hospital; Shariati street
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7021
Email
nasimahdai@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaransadat Mahdavi
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid children's hospital; Shariati street
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7021
Email
nasimahdavi@gmail.com
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
Files will be provided to researchers after sending an email
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to use scientific and practical results of the study
Mentioning references and other ethical and professional principles