Back to resultsEffect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
Primary Purpose
Retinoblastoma
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional other trial for Retinoblastoma
Eligibility Criteria
Inclusion Criteria:
- Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2
Exclusion Criteria:
-
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Dexmedetomidine group
Arm Description
Children diagnosed with retinoblastoma and received exam under anesthesia (EUA) before the age of 30 months, and is not yet 4 years old Children who are undergoing exams and treatment such as EUA, chemoport insertion, or intra-arterial chemotherapy under general anesthesia Sevoflurane is used only for anesthesia
Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. No history of anesthesia
Outcomes
Primary Outcome Measures
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)
Developmental Test
visual-Motor Integration test
Secondary Outcome Measures
Full Information
NCT ID
NCT04700514
First Posted
January 4, 2021
Last Updated
April 21, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04700514
Brief Title
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
Official Title
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
January 20, 2025 (Anticipated)
Study Completion Date
February 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children diagnosed with retinoblastoma and received exam under anesthesia (EUA) before the age of 30 months, and is not yet 4 years old
Children who are undergoing exams and treatment such as EUA, chemoport insertion, or intra-arterial chemotherapy under general anesthesia
Sevoflurane is used only for anesthesia
Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months.
No history of anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Primary Outcome Measure Information:
Title
IQ score at age of 4
Description
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)
Time Frame
year 4
Title
Developmental Test
Description
visual-Motor Integration test
Time Frame
year 4
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hyun Lee, MD, PhD
Phone
01076658848
Ext
82
Email
muslab@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hyun Lee
Phone
01076658848
Ext
82
Email
azrael0609@naver.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun LEE, MD, PhD
Phone
02-2072-3661
Ext
82
Email
muslab@hanmail.net
12. IPD Sharing Statement
Learn more about this trial
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
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