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

Not Applicable

Recruiting

• Conditions: Retinoblastoma
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT04700514
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2021-02-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24
• Primary Completion: 2025-01-20
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	1. Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. 2. No history of anesthesia

Primary Outcome Measures

Name	Time	Method
Developmental Test	year 4	visual-Motor Integration test
IQ score at age of 4	year 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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of