Identification of the effects of Dexmedetomidine and Fentanyl on post intubation hemodynamic changes in children.
Design
randomized clinical trial with control groups, parallel groups , blinded ,randomized
Settings and conduct
this is a randomized clinical trial randomized by random numbers and two side blinded which will be done in imam hussein hospital isfahan 2019-2020.
Participants/Inclusion and exclusion criteria
enter:Children between 6 years to 12 years Candidate Surgery under General Anesthesia
exit: difficult intubation ,duration of intubation more than 30 seconds ,more than one effort for intubation
Intervention groups
the participants are divided into 3 groups with 36 persons.and are divided by random allocation to 3 groups.drugs are coded and anesthesiologist does not know the groups. patients get to operation room after getting 0.1 mg/kg midazolam. first group gets 2 µ g/kg fentanyl 2 minutes before anesthesia,group 2 gets 2 µg/kg nasal dexmedetomidine 1 minutes before anesthesia , and group3 gets 2 µg/kg nasal normal saline .induction of anesthesia is by 2 µg/kg fentanyl and 5 mg/kg sodium thiopental and 0.5 mg/kg atracurium in all patients.
Main outcome variables
hemodynamic changes (systolic blood pressure,diastolic blood pressure, mean arterial pressure ,heart rate) before getting drugs, immediately after induction , immediately before layngoscopy and at 1,3,5,10 minutes after laryngoscopy and intubation in 3 groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191205045619N1
Registration date:2020-04-10, 1399/01/22
Registration timing:registered_while_recruiting
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
kiana golkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 9125
Email address
kianaamir2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-06-14, 1399/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dexmedetomidine and Fentanyl on post intubation hemodynamic changes in children
Public title
Comparison of the effect of Dexmedetomidine and Fentanyl on post intubation hemodynamic changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children between 6 years to 12 years Candidate Surgery under General Anesthesia
Exclusion criteria:
difficult intubation
duration of intubation more than 30 seconds
more than one effort for intubation
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
random allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines are Delivered and Coded in Equal Volumes by the Researcher and the Anesthesiologist dose not know the groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan University Medical Science
Street address
Building No.4, Isfahan University of Medical Sciences, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.358
Health conditions studied
1
Description of health condition studied
Systolic blood pressure
ICD-10 code
ICD-10 code description
2
Description of health condition studied
diastolic blood pressure
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Pulse rate
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Respiratory rate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mean of SBP
Timepoint
before getting drugs, immediately after induction , immediately before layngoscopy and at 1,3,5,10 minutes after laryngoscopy and intubation.
Method of measurement
MONITORING BY MANOMETR
2
Description
mean of DBP
Timepoint
before getting drugs, immediately after induction , immediately before layngoscopy and at 1,3,5,10 minutes after laryngoscopy and intubation.
Method of measurement
MONITORING BY MANOMETR
Secondary outcomes
empty
Intervention groups
1
Description
First group gets 2 mcg/kg fentanyl 1minuties before induction .In all groups we will compare hemodynamic changes before and immediately after intubation.
Category
Treatment - Drugs
2
Description
Second group gets 2 mcg/kg nasal dexmedetomidine 1 minute before induction.all groups we will compare hemodynamic changes before and immediately after intubation.
Category
Treatment - Drugs
3
Description
Third group gets 2 mcg/kg as pelacebo 1 minute before induction.all groups we will compare hemodynamic changes before and immediately after intubation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Amir Shafa
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
815163381
Phone
+98 31 3386 6566
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 9017
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
amir_shafa@med.mui.ac.ir
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
Emam Khomeini
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
amir_shafa@med.mui.ac.ir
Person responsible for updating data
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
Emam Khomeini
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
amir_shafa@med.mui.ac.ir
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
information of participants and results of the study
When the data will become available and for how long
1 year after publish of the letter
To whom data/document is available
all of the researchers that are interested to have access to these information
Under which criteria data/document could be used
by sending request
From where data/document is obtainable
the projects admin
What processes are involved for a request to access data/document