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Clinical Trials/NCT04364945
NCT04364945Active, not recruitingNot Applicable

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

Seoul National University Hospital1 site in 1 country400 target enrollmentStarted: June 17, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
400
Locations
1
Primary Endpoint
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
1 Month to 23 Months (Child)
Sex
All
Accepts 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

Arms & Interventions

Control group

Placebo Comparator

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

Intervention: Sevoflurane (Drug)

Dexmedetomidine-remifentanil(DEX-R) group

Experimental

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.

Intervention: dexmedetomidine (Drug)

Dexmedetomidine-remifentanil(DEX-R) group

Experimental

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.

Intervention: remifentanil (Drug)

Dexmedetomidine-remifentanil(DEX-R) group

Experimental

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.

Intervention: Sevoflurane (Drug)

Outcomes

Primary Outcomes

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

  • Leiter International Performance Scale at age of 30 months(When the patient's age is 30 months old after surgery)
  • Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7(When the patient's age is 7 years old after surgery)
  • Child Behavior Checklist results(When the patient's age become 30 months, 5 years and 7 years old after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ji-Hyun Lee

Clinical Professor

Seoul National University Hospital

Study Sites (1)

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