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NCT04700514 Clinical Trial

Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study

Retinoblastoma Clinical Trial

Official title:
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04700514
Other study ID # 2009-039-1155
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2021
Est. completion date February 20, 2025

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact Ji-Hyun Lee, MD, PhD
Phone 01076658848
Email muslab@hanmail.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date February 20, 2025
Est. primary completion date January 20, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria: - Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2 Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine (1 mcg/kg loading for 10 min, then 1 mcg/kg/min continuous infusion) is used with sevoflurane in every time of general anesthesia

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary IQ score at age of 4 Korean-Wechsler Preschool and Primary Scale of Intelligence test (score >131, high; score 116-130, high-normal; socre 85-115, normal; score 70-84; low-normal; score <69; low) year 4
Primary Developmental Test visual-Motor Integration test year 4
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