Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 8, 2021
CompletedStudy Start
First participant enrolled
February 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2025
CompletedApril 24, 2023
April 1, 2023
4 years
January 4, 2021
April 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Developmental Test
visual-Motor Integration test
year 4
Study Arms (2)
Control group
NO INTERVENTION1. Children diagnosed with retinoblastoma and received exam under anesthesia (EUA) before the age of 30 months, and is not yet 4 years old 2. Children who are undergoing exams and treatment such as EUA, chemoport insertion, or intra-arterial chemotherapy under general anesthesia 3. Sevoflurane is used only for anesthesia
Dexmedetomidine group
EXPERIMENTAL1. Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. 2. No history of anesthesia
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 8, 2021
Study Start
February 5, 2021
Primary Completion
January 20, 2025
Study Completion
February 20, 2025
Last Updated
April 24, 2023
Record last verified: 2023-04