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

N/AActive Not RecruitingNCT04364945

Seoul National University Hospital400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

400

Conditions

Anesthesia and Neurotoxicity

Interventions

dexmedetomidineDRUG

administration of dexmedetomidine 1 mcg/kg/hr

remifentanilDRUG

administration of remifentanil 0.1-0.2 mcg/kg/min

SevofluraneDRUG

Anesthesia is maintained using sevoflurane.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 23 Months

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Other, South Korea

Outcomes

Primary Outcomes

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

categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline

Time frame: When the patient's age is 5 years after surgery

Secondary Outcomes

Leiter International Performance Scale at age of 30 months

Korean version of the Leiter International Performance Scale-Revised (Leiter-R), categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline

Time frame: When the patient's age is 30 months old after surgery

Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7

categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline

Time frame: When the patient's age is 7 years old after surgery

Child Behavior Checklist results

Child Behavior Checklist results at age of 30 months, 5 years and 7 years

Time frame: When the patient's age become 30 months, 5 years and 7 years old after surgery

Data from ClinicalTrials.gov

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