Comparing the hemodynamic effects of nebulized Dexmedetomidine and nebulized Lidocaine in children undergoing fiberoptic bronchoscopy
Design
This is a double-blind randomized clinical trial with parallel groups. The sample size is 25 people in each group.Randomization using random numbers table.
Settings and conduct
This study will be conducted at Imam Hossein Children's Hospital in Isfahan.Patient, lung specialist and evaluator are blinded to patient group allocation
Participants/Inclusion and exclusion criteria
The inclusion criteria will be 1 to 6 years old, being a candidate for fiberoptic bronchoscopy of ASA1 and ASA2 classes, and having consent for participation.The non-entry criteria will be having any diagnosed cardiac or liver diseases, having a fever, existence of crackle or bronchi when hearing the lungs, intubation, and using other anesthetics or sedative drugs before the bronchoscopy
Intervention groups
Intervention group 1:will receive premedication with 2 µg/kg of nebulized Dexmedetomidine, Intervention group 2: will receive premedication with nebulized Lidocaine 1% (4 mg/kg) and control group will receive premedication with saline 0.9%
Main outcome variables
Hemodynamic changes (Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and heart rate)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160301026866N9
Registration date:2018-10-06, 1397/07/14
Registration timing:registered_while_recruiting
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Amir Shafa
Name of organization / entity
Isfahan University of Medical Sciences, Imam hossein Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2655
Email address
amir_shafa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the hemodynamic effects of nebulized Dexmedetomidine and nebulized Lidocaine in children undergoing fiberoptic bronchoscopy
Public title
Nebulized Dexmedetomidine and Nebulized Lidocaine in children undergoing fiberoptic bronchoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 1 and 6 years, Candid for fibropetic bronchoscopy, ASAI,ASAII, Satisfaction to enter the study
Exclusion criteria:
The non-entry criteria are having any diagnosed cardiac or liver diseases, having a fever, existence of crackle or ronchi when hearing the lungs, intubation, and using other anesthetics or sedative drugs before the bronchoscopy
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient, lung specialist and evaluator are blinded to patient group allocation.
Placebo
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
Isfahan University of Medical Sciences, Hezarjrib Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
ir.mui.rec.1395.3.505
Health conditions studied
1
Description of health condition studied
Broncoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemodynamic effects
Timepoint
5,10,15,20 minutes after bronchoscopy
Method of measurement
Anesthetic monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:will receive premedication with 2 µg/kg of nebulized Dexmedetomidine by recovery nurse
Category
Treatment - Drugs
2
Description
Intervention group 2: will receive premedication with nebulized Lidocaine 1% (4 mg/kg) by recovery nurse
Category
Treatment - Drugs
3
Description
Control group: will receive premedication with saline 0.9% by recovery nurse
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamhossein hospital
Full name of responsible person
Amir Shafa
Street address
Emamhossein hospital, Emamkhomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezarjrib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emamhossein hospital, Emamkhomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Fax
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
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emamhossein hospital, Emamkhomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
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
Amir Shafa
Position
Assiatant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emamhossein hospital, Emamkhomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.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
All data can be shared
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Access is available to all researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Amir shafa: shafa_amir@yahoo.com
What processes are involved for a request to access data/document