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The comparison of ECG changes of ondansetron and dexamethasone in cochlear implantation

The comparison of the effect of ondansetron and dexamethason on QT interval prolongation in pediatrics undergoing cochlear implantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016122031487N1
Enrollment
60
Registered
2017-05-10
Start date
2015-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

long QT syndrom. Other specified conduction disorders

Interventions

Intervention 1: Intervention Group 1: Ondansetron( 0.2 milligram per kilogram). Intervention 2: Intervention Group2: Dexamethason (0.1 milligram per kilogram). Intervention 3: Control Group: Patient's
Treatment - Drugs
Intervention Group 1: Ondansetron( 0.2 milligram per kilogram)
Intervention Group2: Dexamethason (0.1 milligram per kilogram)
Control Group: Patient's baseline ECG before administration of drugs

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 18 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Prolonged QT interval. Timepoint: 5 and 15 minutes after drug administrationd. Method of measurement: ECG monitoring and calculated by the cardiologist.

Secondary

MeasureTime frame
Vomit. Timepoint: After the surgery. Method of measurement: inspection.;Nausea. Timepoint: After the surgery. Method of measurement: inspection.;Prolonged Tp-e interval. Timepoint: 5 and 15 minutes after drug administration. Method of measurement: ECG monitoring and calculated by the cardiologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Reza Safaeian

Rasool Akram Hospital

rezasafa@yahoo.com+98 21 6435 2326

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026