Purpose: Pediatrics candidate for cochlear implantation often need surgery at an early age. Administration of antiemetic drugs cause complications such as QT prolongation. Therefore we designed this study to evaluate the effect of drugs applied on QT prolongation.
Methods: In this randomized controlled clinical trial 60 patients aged 6months to 18 years, candidate for cochlear implantation were enrolled. Known cases of jervell lange nielson syndrome and patients with cardiac complications, ECG and electrolytes abnormalities, those who used drugs which caused QT prolongation and with family history of QT prolongation, were excluded from the study.1 hour before the entrance of the patients to the operating room midazolam was administered 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 administered as premedication. Sevoflorane 8% and atracorium (0.5mg /kg) was used for induction. Isoflurane 1.2% was applied as maintanance. Using the random number table patients were divided to 2 groups; group A who received dexamethasone (0.1mg/kg) and group B who received ondansetron (0.2 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:IRCT2016122031487N1
Registration date:2017-05-10, 1396/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-10, 1396/02/20
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 University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of ondansetron and dexamethason on QT interval prolongation in pediatrics undergoing cochlear implantation
Public title
The comparison of ECG changes of ondansetron and dexamethasone in cochlear implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 6 months to 18 years candidate for cochlear implantation.
Exclusion criteria: Known case of jervell lange nielson syndrome; patients with any cardiac disease; ECG abnormalities; electrolyte abnormalities; usage of drugs 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:
60
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
Ethics committee of Iran university of medical sciences
Street address
school of Medicine, Iran university of medical sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2017-03-01, 1395/12/11
Ethics committee reference number
IR.IUMS.REC 1395.9311174024
Health conditions studied
1
Description of health condition studied
long QT syndrom
ICD-10 code
I45.8
ICD-10 code description
Other specified conduction disorders
Primary outcomes
1
Description
Prolonged QT interval
Timepoint
5 and 15 minutes after drug administrationd
Method of measurement
ECG monitoring and calculated by the cardiologist
Secondary outcomes
1
Description
Vomit
Timepoint
After the surgery
Method of measurement
inspection
2
Description
Nausea
Timepoint
After the surgery
Method of measurement
inspection
3
Description
Prolonged Tp-e interval
Timepoint
5 and 15 minutes after drug administration
Method of measurement
ECG monitoring and calculated by the cardiologist
Intervention groups
1
Description
Intervention Group 1: Ondansetron( 0.2 milligram per kilogram)
Category
Treatment - Drugs
2
Description
Intervention Group2: Dexamethason (0.1 milligram per kilogram)
Category
Treatment - Drugs
3
Description
Control Group: Patient's baseline ECG before administration of drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital, Satarkhan street, Tehran
Full name of responsible person
Dr Reza Safaian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Reza Safaeian
Street address
School of Medicine, Iran university of medical sciences, Hemmat Highway
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
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
Rasool Akram Hospital
Full name of responsible person
Dr Reza Safaeian
Position
Associate Professor
Other areas of specialty/work
Street address
Sattar-khan Avn.
City
Teharn
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 Safaeian
Position
Associate Professor
Other areas of specialty/work
Street address
Sattar-khan Avn.
City
Teharn
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 Safaeian
Position
Associate professor
Other areas of specialty/work
Street address
Sattar-khan Avn.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)