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

Seoul National University

Status: Active, not recruiting

Conditions: Anesthesia and Neurotoxicity

Treatments: Drug: remifentanil; Drug: dexmedetomidine; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT04364945

H2003-234-1115

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 23 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

400 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Sevoflurane

Dexmedetomidine-remifentanil(DEX-R) group

Experimental group

Description:

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.

Treatment:

Drug: Sevoflurane

Drug: dexmedetomidine

Drug: remifentanil