Anesthesia and Neurotoxicity
Conditions
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.
Interventions
DRUGdexmedetomidine
administration of dexmedetomidine 1 mcg/kg/hr
DRUGremifentanil
administration of remifentanil 0.1-0.2 mcg/kg/min
DRUGSevoflurane
Anesthesia is maintained using sevoflurane.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leiter International Performance Scale at age of 30 months | 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 |
| Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7 | 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 |
| Child Behavior Checklist results | 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 |
Countries
South Korea
Outcome results
None listed