An interventional study of dexmedetomidine and remifentanil in Anesthesia and Neurotoxicity, sponsored by Seoul National University Hospital. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 1 Month to 23 Months. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other
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.
137 studies on the registry are indexed under Neurotoxicity Syndromes; 16 are open to participants now.
This study's planned enrollment of 400 is above the median of 92 across 92 interventional studies indexed under Neurotoxicity Syndromes.
Browse Neurotoxicity Syndromes studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
Drug: Sevoflurane
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: dexmedetomidine · Drug: remifentanil · Drug: Sevoflurane
administration of dexmedetomidine 1 mcg/kg/hr
administration of remifentanil 0.1-0.2 mcg/kg/min
Anesthesia is maintained using sevoflurane.
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
Time frame: When the patient's age is 5 years 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
Time frame: 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
Time frame: When the patient's age is 7 years old after surgery
Child Behavior Checklist results
Child Behavior Checklist results at age of 30 months, 5 years and 7 years
Time frame: When the patient's age become 30 months, 5 years and 7 years old after surgery
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital