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

April 21, 2023 updated by: Ji-Hyun Lee, Seoul National University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Other
      • Seoul, Other, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
Drug: Sevoflurane
Anesthesia is maintained using sevoflurane.
Experimental: Dexmedetomidine-remifentanil(DEX-R) group
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.
Drug: Sevoflurane
Anesthesia is maintained using sevoflurane.
Drug: dexmedetomidine
administration of dexmedetomidine 1 mcg/kg/hr
Drug: remifentanil
administration of remifentanil 0.1-0.2 mcg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
Time Frame: When the patient's age is 5 years after surgery
When the patient's age is 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leiter International Performance Scale at age of 2
Time Frame: When the patient's age is 2 years old after surgery
When the patient's age is 2 years old after surgery
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
When the patient's age is 7 years old after surgery
Child Behavior Checklist results
Time Frame: When the patient's age is 2, 5 and 7 years old after surgery
Child Behavior Checklist results at age of 2, 5, 7
When the patient's age is 2, 5 and 7 years old after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ji-Hyun Lee, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Anticipated)

May 30, 2028

Study Completion (Anticipated)

December 30, 2028

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2003-234-1115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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