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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2028-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia and Neurotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

Sevoflurane

Intervention Type DRUG

Anesthesia is maintained using sevoflurane.

Dexmedetomidine-remifentanil(DEX-R) group

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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

administration of dexmedetomidine 1 mcg/kg/hr

remifentanil

Intervention Type DRUG

administration of remifentanil 0.1-0.2 mcg/kg/min

Sevoflurane

Intervention Type DRUG

Anesthesia is maintained using sevoflurane.

Interventions

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dexmedetomidine

administration of dexmedetomidine 1 mcg/kg/hr

Intervention Type DRUG

remifentanil

administration of remifentanil 0.1-0.2 mcg/kg/min

Intervention Type DRUG

Sevoflurane

Anesthesia is maintained using sevoflurane.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children under 2 years of age who underwent general anesthesia for elective surgeries inlcuding urology, surgery, plastic surgery, orthopedics, and otolaryngology, etc, which were non-staged and non-repetitive procedures
* 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
* Developmental delay identified through K-DST results
* Additional exposure to general anesthetics or sedative drugs during follow-up

Minimum Eligible Age

1 Month

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No