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Clinical Trials in South Korea / NCT04364945
Active, not recruiting Not applicable

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

NCT04364945 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2020-06-17
Last updated
2024-11-19

Condition(s) studied

Anesthesia and Neurotoxicity

Investigational drug(s) / intervention(s)

dexmedetomidine →remifentanil →Sevoflurane →

dexmedetomidine: administration of dexmedetomidine 1 mcg/kg/hr

remifentanil: administration of remifentanil 0.1-0.2 mcg/kg/min

Sevoflurane: Anesthesia is maintained using sevoflurane.

Study 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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
23 Months
Healthy volunteers
No
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

Primary outcome measure(s)

  • Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5 — When the patient's age is 5 years after surgery
    categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Other

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04364945 on ClinicalTrials.gov ↗ ← All trials in South Korea