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Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/Behavioral Assessment Results in Children

Primary Purpose

Anesthesia and Neurotoxicity

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine
remifentanil
Sevoflurane
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia and Neurotoxicity

Eligibility Criteria

undefined - 23 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children under 2 years of age who underwent general anesthesia for elective surgeries of urology, surgery, plastic surgery, orthopedics, and otolaryngology
  • American Society of Anesthesiology Physical Status I, II

Exclusion Criteria:

  • Allergies to narcotic analgesics
  • With massive bleeding or shock
  • Heart, lung, kidney or liver disease
  • Central / peripheral nervous system disease and disorder
  • Any physical deformity and disorder, genetic disease, chromosomal disease
  • Previous history of general anesthesia or sedation
  • Additional exposure to general anesthetics or sedative drugs during follow-up

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Dexmedetomidine-remifentanil(DEX-R) group

Arm Description

General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.

General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg/hr) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.

Outcomes

Primary Outcome Measures

Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5

Secondary Outcome Measures

Leiter International Performance Scale at age of 2
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7
Child Behavior Checklist results
Child Behavior Checklist results at age of 2, 5, 7

Full Information

First Posted
April 24, 2020
Last Updated
April 21, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04364945
Brief Title
Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/Behavioral Assessment Results in Children
Official Title
Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/Behavioral Assessment Results in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
May 30, 2028 (Anticipated)
Study Completion Date
December 30, 2028 (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
No

5. Study Description

Brief Summary
In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia and Neurotoxicity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
Arm Title
Dexmedetomidine-remifentanil(DEX-R) group
Arm Type
Experimental
Arm Description
General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg/hr) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
administration of dexmedetomidine 1 mcg/kg/hr
Intervention Type
Drug
Intervention Name(s)
remifentanil
Intervention Description
administration of remifentanil 0.1-0.2 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia is maintained using sevoflurane.
Primary Outcome Measure Information:
Title
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
Time Frame
When the patient's age is 5 years after surgery
Secondary Outcome Measure Information:
Title
Leiter International Performance Scale at age of 2
Time Frame
When the patient's age is 2 years old after surgery
Title
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7
Time Frame
When the patient's age is 7 years old after surgery
Title
Child Behavior Checklist results
Description
Child Behavior Checklist results at age of 2, 5, 7
Time Frame
When the patient's age is 2, 5 and 7 years old after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children under 2 years of age who underwent general anesthesia for elective surgeries of urology, surgery, plastic surgery, orthopedics, and otolaryngology American Society of Anesthesiology Physical Status I, II Exclusion Criteria: Allergies to narcotic analgesics With massive bleeding or shock Heart, lung, kidney or liver disease Central / peripheral nervous system disease and disorder Any physical deformity and disorder, genetic disease, chromosomal disease Previous history of general anesthesia or sedation Additional exposure to general anesthetics or sedative drugs during follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Other
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

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Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/Behavioral Assessment Results in Children

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