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

Anesthesia and Neurotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04364945
• Other study ID #: H2003-234-1115
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: December 30, 2028

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 30, 2028
• Est. primary completion date: May 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia and Neurotoxicity
• Neurotoxicity Syndromes

Intervention

Drug:
• dexmedetomidine
administration of dexmedetomidine 1 mcg/kg/hr
• remifentanil
administration of remifentanil 0.1-0.2 mcg/kg/min
• Sevoflurane
Anesthesia is maintained using sevoflurane.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Other

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5		When the patient's age is 5 years after surgery
Secondary	Leiter International Performance Scale at age of 2		When the patient's age is 2 years old after surgery
Secondary	Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7		When the patient's age is 7 years old after surgery
Secondary	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