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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia and Neurotoxicity
• Intervention / Treatment: Drug: Sevoflurane; Drug: dexmedetomidine; Drug: remifentanil

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Other
    • Seoul, Other, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.	Drug: Sevoflurane; Anesthesia is maintained using sevoflurane.
Experimental: 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.	Drug: Sevoflurane; Anesthesia is maintained using sevoflurane.; Drug: dexmedetomidine; administration of dexmedetomidine 1 mcg/kg/hr; Drug: remifentanil; administration of remifentanil 0.1-0.2 mcg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5	categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline	When the patient's age is 5 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior Checklist results	Child Behavior Checklist results at age of 30 months, 5 years and 7 years	When the patient's age become 30 months, 5 years and 7 years old after surgery
Leiter International Performance Scale at age of 30 months	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	When the patient's age is 30 months old after surgery
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7	categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline	When the patient's age is 7 years old after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Ji-Hyun Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Chemically-Induced Disorders; Poisoning; Neurotoxicity Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Anesthetics, Inhalation; Remifentanil; Sevoflurane; Dexmedetomidine
• Other Study ID Numbers: H2003-234-1115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No