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

Study Overview
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Brief Summary
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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.

Official Title
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Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/Behavioral Assessment Results in Children

Conditions
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Anesthesia and Neurotoxicity

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: remifentanil
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children under 2 years of age who underwent general anesthesia for elective surgeries of urology, surgery, plastic surgery, orthopedics, and otolaryngology 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 Additional exposure to general anesthetics or sedative drugs during follow-up

Ages Eligible for Study
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Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. | Drug: Sevoflurane<br>* Anesthesia is maintained using sevoflurane.<br>|
| Experimental: Dexmedetomidine-remifentanil(DEX-R) group<br>General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg/hr) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. | Drug: dexmedetomidine<br>* administration of dexmedetomidine 1 mcg/kg/hr<br>Drug: remifentanil<br>* administration of remifentanil 0.1-0.2 mcg/kg/min<br>Drug: Sevoflurane<br>* Anesthesia is maintained using sevoflurane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5 |  | When the patient's age is 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leiter International Performance Scale at age of 2 |  | When the patient's age is 2 years 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 | Child Behavior Checklist results at age of 2, 5, 7 | When the patient's age is 2, 5 and 7 years old after surgery |