The aim of this study is to compare the effect of anesthesia with sevoflurane and propofol-remifentanil on stapedius reflex in children undergoing cochlear implant surgery. A total of 36 children, aged 6 months to 7 years, ASA І-ІІ, involving severe or complete neural hearing loss undergoing cochlear implant surgery in children’s hospital will be allocated into two groups. The anesthesia will be maintained with infusion of remifentanil-propofol in one group and sevoflurane in the other group. Both groups will receive O2-N2O in concentration of 50%-50% for maintenance of anesthesia. After induction of anesthesia, bispectral index will be used for monitoring the level of anesthesia and will be maintained in 50±10 limit. Morphine, 0.1 mg/kg, will be administered for postoperative pain in group 1, 15-30 minute before termination of surgery. Stapedius reflex and hemodynamic changes will be compared during anesthesia and recovery room between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104026022N3
Registration date:2011-05-07, 1390/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-07, 1390/02/17
Registrant information
Name
Reza Taheri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2250
Email address
taherireza@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Siences
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2012-11-01, 1391/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of propofol-remifentanil and sevoflurane effects on stapedius reflex in children undergoing cochlear implant surgery
Public title
Effects of anesthetics on stapedius reflex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children with severe to profound sensory neural hearing loss who are candidate for cochlear implant surgery
Exclusion criteria: Children with a history of adverse reaction to any study drug
Age
To 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Ave,
City
Tabriz
Postal code
Approval date
2010-10-16, 1389/07/24
Ethics committee reference number
5/4/5447
Health conditions studied
1
Description of health condition studied
Anesthesia
ICD-10 code
Y48.0
ICD-10 code description
Anaesthetics and therapeutic gases
Primary outcomes
1
Description
Stapedius reflex
Timepoint
evaluation is done while testing
Method of measurement
by Nucleus Freedom cochlear implant divice
Secondary outcomes
1
Description
Hemodynamic changes
Timepoint
every 10 minutes during anesthesia
Method of measurement
by electrocardiography and blood pressure measurment
Intervention groups
1
Description
Intervention group will receive remifentanil (0.2-0.5mcg/kg/min) + propofol (100-150mcg/kg/min) during 4 hours anesthesia
Category
Treatment - Drugs
2
Description
Control group will receive 2-3% MAC sevoflurane through the ventilator, during 4 hours anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Alireza ostad rahimi
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Children hospital of Tabriz, Sheshgelan avenue
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
dr.reza.taheri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Children hospital of Tabriz, Sheshgelan avenue
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
dr.reza.taheri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Position
Anesthesiologist
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
+98 914 102 4249
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)