Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children
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
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
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
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
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
Ji-Hyun Lee
Clinical Professor
Seoul National University Hospital