A comparative trial on hemodynamic changes caused by anesthesia with propofol-remifentanil and isoflurane-remifentanil during cleft palate repair surgery in children under 3 years old
This study aimed to compare hemodynamic changes during cleft palate repair in patients anesthetized with isoflurane-remifentanil and propofol-remifentanil.
Design
Clinical trial , phase 2 , patients under 3 years old , who are candidated for cleft palate repair surgery , will be allocated to 2 groups of recieving isoflurane-remifentanil or propofol-remifentanil, by simple randomized method .
Settings and conduct
In this randomized, double blind study, 100 patients under 3 years old candidated for cleft palate repair surgery will be allocated to two groups of 50 patients to receive either isoflurane-remifentanil or propofol-remifentanil for maintaining anesthesia.
Participants/Inclusion and exclusion criteria
Children under 3 years old candidated for cleft palate repair surgery; without any congenital cardiac or pulmonary diseases
Intervention groups
patients anesthetized with isoflurane-remifentanil and propofol-remifentanil.
Main outcome variables
Blood pressure
Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039739N1
Registration date:2018-07-27, 1397/05/05
Registration timing:registered_while_recruiting
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Mohammadreza Habibzadeh siahroodkolaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3532 0551
Email address
M.habibzadeh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative trial on hemodynamic changes caused by anesthesia with propofol-remifentanil and isoflurane-remifentanil during cleft palate repair surgery in children under 3 years old
Public title
A comparative trial on hemodynamic changes caused by anesthesia with propofol-remifentanil and isoflurane-remifentanil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age < 3 years old
American Society of Anesthesiologists (ASA) Class I
Exclusion criteria:
Congenital cardiac or pulmonary diseases
Age
To 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization(random number table)
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients and their parents are not aware of the kind of used anesthetic drugs
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of medical sciences
Street address
Esfahan university of medical sciences , Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
1395.3.95215
Health conditions studied
1
Description of health condition studied
Anesthesia in cleft palate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure
Timepoint
q 15 min
Method of measurement
Manometer
2
Description
Heart rate
Timepoint
q 15 min
Method of measurement
Heart monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: propofol and remifentanil (0/5 microg/kg/min )
Category
Treatment - Drugs
2
Description
Intervention group: isoflurane 1% and remifentanil(0/5 microg/kg/min )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein hospital
Full name of responsible person
Mohammadreza Habibzadeh
Street address
Emam Khomeini
City
Esfahan
Province
Isfehan
Postal code
ندارد
Email
gsmhabibzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Street address
Hezarjerib Ave.
City
Esfahan
Province
Alborz
Postal code
ندارد
Email
gsmhabibzadeh@yahoo.com
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
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available