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Active, Not Recruiting

NCT Number: NCT04364945

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anesthesia and Neurotoxicity Chemically-Induced Disorders Nervous System Diseases Neurotoxicity Syndromes Poisoning

Age range

1 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Other, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

administration of dexmedetomidine 1 mcg/kg/hr

Remifentanil

Drug

administration of remifentanil 0.1-0.2 mcg/kg/min

Sevoflurane

Drug

Anesthesia is maintained using sevoflurane.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Leiter International Performance Scale at age of 30 months

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

    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

  2. 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

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

  3. Child Behavior Checklist results

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

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2020
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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