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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04700514

Collaborator

(none)

Enrollment

Location

Arms

48.5

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma	Drug: Dexmedetomidine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 5, 2021

Anticipated Primary Completion Date :

Jan 20, 2025

Anticipated Study Completion Date :

Feb 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group 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
Experimental: Dexmedetomidine group Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. No history of anesthesia	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

Arm

Intervention/Treatment

No Intervention: Control group

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

Experimental: Dexmedetomidine group

Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. No history of anesthesia

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

Outcome Measures

Primary Outcome Measures

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)
Developmental Test [year 4]
visual-Motor Integration test

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji-Hyun Lee, Clinical Associate Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04700514

Other Study ID Numbers:

2009-039-1155

First Posted:

Jan 8, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinoblastoma

Dexmedetomidine

Study Results

No Results Posted as of Nov 19, 2021