purpose : the comparison effect of propofolel and sevoflurane on the QT interval prolongation in pediatrics undergoing cochlear implantation methods : in this randomized controlled clinical trial 64 patients aged 6 months to 18 years, candidate for cochlear implantation were enrolled .
known case of jervell lange nielson syndrome , pations with any cardiac disease, ECG abnormalitie, electrolyte abnormalitie, usage of drags which prolong the QT interval and family history of QT prolongation, were excluded for the study . 1 hours before enterance of the patients to the operating room midazolam was administrated 0.5 - 0.75 mg/kg orally and 0.05 - 0.1 mg/kg intravenously . 12 leads ECG was applied and baseline strips were taken for all participant . fentanyl 2 ug/kg was administrated premedication . using the random number table patients were divided to 2 groups ; group A who received sevoflurane with standard mac induction and group B who received propofole ( 2.5 mg/kg ) . 5 and 15 minutes after drug administration ECG was performed and evaluated for QT prolongation and other abnormalities between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082131487N2
Registration date:2017-10-16, 1396/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
iran medicine science university
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the comparison effect of propofolel and sevoflurane on the QT interval prolongation in pediatrics undergoing cochlear implantation
Public title
the comparison of ECG changes propofole and sevoflurane cochlear implantation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion critria : patients aged 6 months to 18years condidate for cochlear implantation . exclusion critria: known case of jervell lange nielson syndrome , patients with any cardiac disease, ECG abnormalitie, electrolyte abnormalitie, usage of drags which prolong the QT interval and family history of QT prolongation .
Age
From 6 months old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
iran university of medical sciences
Street address
iran university of medical sciences , hemmat highway
City
tehran
Postal code
Approval date
2017-05-06, 1396/02/16
Ethics committee reference number
IR.IUMS.REC1396.9311174019
Health conditions studied
1
Description of health condition studied
cochlear implantation
ICD-10 code
DISEASES O
ICD-10 code description
other specified diseases of inner ear(h83.8(
Primary outcomes
1
Description
QT INTERVAL
Timepoint
AFTER THE INDACTION
Method of measurement
ECG MONITORING AND CALCULATED BY THE CARDIOLOGIST
Secondary outcomes
1
Description
PROLONGET TP-E INTERVALL
Timepoint
5 AND 15 MINIUTE AFTER DRAG ADMINISRATION
Method of measurement
ECG MONITORING AND CALCULATED BY CARDIOLOGIST
Intervention groups
1
Description
Intervention Group1:2.5mg/kg propofol for induction
Category
Treatment - Drugs
2
Description
Intervention Group2:sevofeloran with mac 8% for induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
rasool akram hospital
Full name of responsible person
DR.reza safaeeian
Street address
sattar-khan avn
City
tehran
2
Recruitment center
Name of recruitment center
rasool akram hospital
Full name of responsible person
DR.reza safaeeian
Street address
sattar-khan avn
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
iran university of medical sciences
Full name of responsible person
DR.alireza poornajafiand
Street address
firozgar haspital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
iran university of medical sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
iran university of medical sciences
Full name of responsible person
DR.alireza poornajafiand
Street address
firozgar haspital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
iran university of medical sciences
Proportion provided by this source
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
rasool akram hospital
Full name of responsible person
DR.reza safaeeian
Position
associate professor
Other areas of specialty/work
Street address
sattar-khan avn
City
tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
rezasafa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
rasool akram hospital
Full name of responsible person
DR.reza safaeeian
Position
associate professor
Other areas of specialty/work
Street address
sattar-khan ave
City
tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
rezasafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
rasool akram hospital
Full name of responsible person
DR.reza safaeeian
Position
associate professor
Other areas of specialty/work
Street address
sattar-khan ave
City
tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)