Comparison the effect of intranasal dexmedetomidine and remifentanil on reduction of hemodynamic changes after intubation in children ages 6 to 12 years old under general anesthesia
Comparison the effect of intranasal dexmedetomidine and remifentanil on reduction of hemodynamic changes after intubation in children ages 6 to 12 years old under general anesthesia
Design
This study is a double-blind, randomized, clinical trial study. The minimum required sample size was determined using the formula 35 in each group. Patients are classified into three groups using the random numbers table.
Settings and conduct
This clinical trial study will be done at Imam Hossein Hospital in Isfahan.The way of blinding is that the drugs are prepared and encoded in similar syringes and similar volumes.And the researcher and the anesthetist and the patient do not know about the location of the patients in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes all children ages 6 to 12 years of age who have a general anesthetic candidate with ASAI and ASAII grades and are satisfied with the patient's parents to participate in the study.The criteria for not attending the study include children under 6 years of age and over 12 years of age, underlying illness (inherited and genetic diseases, metabolic diseases, etc.), and parents' disagreement for participation in the study.
Intervention groups
Intervention group 1: Two minutes before anesthesia induction received 4 μg / kg of Intranasal remifentanil .Intervention group 2: Two minutes before anesthesia induction, 2 μg / kg intranasal Dexmedetomidine will receive .Control group: Two minutes before anesthesia induction, 1cc of intranasal normal saline will receive.
Main outcome variables
Hemodynamic change( 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:IRCT20160301026866N7
Registration date:2018-09-04, 1397/06/13
Registration timing:prospective
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intranasal dexmedetomidine and remifentanil on reduction of hemodynamic changes after intubation in children ages 6 to 12 years old under general anesthesia
Public title
Intranasal Dexmedetomidine and Remifentanil and hemodynamic changes after intubation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: all children ages 6 to 12 years of age with general anesthetics, ASAI and ASAII grades, and consent from the parents of the patient to participate in the study.
Exclusion criteria:
The criteria for not attending the study include children under 6 years of age and over 12 years of age, underlying illness (inherited and genetic diseases, metabolic diseases, etc.), and parents' disagreement for participation in the study
Age
From 6 years old to 12 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:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are prepared and encoded in syringes of equal volume, Drugs are prescribed by an anesthetist who is not known to the groups.The consequences of prescribing the drug are recorded by the researcher.
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
City
Isfahan
Province
Isfehan
Postal code
8185665843
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
ir.mui.rec.1396.3.091
Health conditions studied
1
Description of health condition studied
Hemodynamic and Respiratory complications after intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemodynamic change
Timepoint
One minute after the drug is given and one minute after the intubation
Method of measurement
Anesthetic monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Two minutes before anesthesia induction received 4 μg / kg of Intranasal remifentanil .Intervention group 2: Two minutes before anesthesia induction, 2 μg / kg intranasal Dexmedetomidine will receive .Control group: Two minutes before anesthesia induction, 1cc of intranasal normal saline will receive.
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 13 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
Isfahan University of Medical Sciences, Hezarjrib Ave
City
Isfahan
Province
Isfehan
Postal code
81856665843
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
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
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
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
The total data can be shared after Unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Free access
Under which criteria data/document could be used
Accessible for everyone without a precondition
From where data/document is obtainable
Amir Shafa: shafa_amir@yahoo.com
What processes are involved for a request to access data/document