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Neurodevelopmental outcome after standard dose sevoflurane versus low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia in young children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512385-34-00
Acronym
TREX
Enrollment
150
Registered
2024-07-09
Start date
2020-09-30
Completion date
Unknown
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children under the age of 2 years having surgery lasting at least 2 hours

Brief summary

Full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed

Detailed description

Neuropsychological tests • Language (Test TLV - Language evaluation) • Attention/Executive Function/impulse control: (NEPSY-2: Statue Subtest) • Memory: (NEPSY-2: Narrative memory) • Adaptive Behaviour: (Adaptive Behavior Assessment System, 2rd Ed 0-5 years) • Clinical Behaviour: (Child Behavior Checklist for ages 1.5-5 years) • Executive Function: (Behavior Rating of Executive Function- Preschool), Anaesthesia - Incidence of intra-operative hypotension - Intra-operative bradycardia - Post-operative pain (FLACC Scale: Face, Legs, Activity, Cry, Consolability Scale) - Time to recovery, Safety - Nature and incidence of adverse events and serious adverse events

Interventions

DRUGSEVOFLURANE
DRUGDEXMEDETOMIDINE HYDROCHLORIDE

Sponsors

Giannina Gaslini Institute For Scientific Hospitalization And Care
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed

Secondary

MeasureTime frame
Neuropsychological tests • Language (Test TLV - Language evaluation) • Attention/Executive Function/impulse control: (NEPSY-2: Statue Subtest) • Memory: (NEPSY-2: Narrative memory) • Adaptive Behaviour: (Adaptive Behavior Assessment System, 2rd Ed 0-5 years) • Clinical Behaviour: (Child Behavior Checklist for ages 1.5-5 years) • Executive Function: (Behavior Rating of Executive Function- Preschool), Anaesthesia - Incidence of intra-operative hypotension - Intra-operative bradycardia - Post-operative pain (FLACC Scale: Face, Legs, Activity, Cry, Consolability Scale) - Time to recovery, Safety - Nature and incidence of adverse events and serious adverse events

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026