2024-512385-34-00
Recruiting
Phase 3
Neurodevelopmental outcome after standard dose sevoflurane versus low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia in young children
Giannina Gaslini Institute For Scientific Hospitalization And Care8 sites in 1 country150 target enrollmentStarted: July 9, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Giannina Gaslini Institute For Scientific Hospitalization And Care
- Enrollment
- 150
- Locations
- 8
- Primary Endpoint
- Full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed
Overview
Brief Summary
Determine if, in children less than 2 years of age having anaesthesia expected to last 2 hours or longer, low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia is superior to standard dose sevoflurane anaesthesia in terms of the global cognitive function as assessed by the full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed at 3 years of age.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Younger than 2 years old (chronological age)
- •Scheduled for anaesthesia that is expected to last at least 2 hours (and/or total operating room time is scheduled to be at least 2.5 hours) and for a maximum of 6 hours
- •Type of surgery that can be included, assuming patients do not meet exclusion criteria, are the following: a) Craniofacial (i.e., isolated cleft lip, craniosynostosis, dermoid cysts of the scalp, etc.) b) Thoracic (i.e., isolated lung malformations, diaphragmatic hernia Morgagni type, etc.) c) Abdominal (i.e., Hirschsprung disease, Meckel resection, etc.) d) Urologic (i.e., hypospadias, laparoscopic/robotic hydronephrosis repair, etc.) e) Orthopaedic (i.e., congenital hip dislocation, bilateral congenital clubfoot, etc.) f) Neurosurgical (i.e., isolated spine tethering, brachial plexus repair, etc.)
Exclusion Criteria
- •Known neurologic, chromosomal or congenital anomaly which is likely to be associated with poor neurobehavioural outcome
- •Previous adverse reaction to any anaesthetic
- •Circumstances likely to make long-term follow-up impossible
- •Living in a household where the primary language spoken at home is not a language in which we can administer the Wechsler Preschool and Primary School Intelligence Scale
- •Planned postoperative sedation with any agent except opioids (e.g., benzodiazepines, dexmedetomidine, ketamine, barbiturates, propofol, clonidine, chloral hydrate, and other non-opioid sedatives). For example, if such sedation is planned for post-operative ventilation
- •Known hypersensitivity to the study investigational medicinal products (IMPs) and their excipients
- •Renal impairment, defined as eGFR < 60 mL/min/1.73 m2, as calculated with Schwartz formula (eGFR = 0.5 × height (cm)/plasma creatinine)
- •Hepatic impairment, defined as levels of AST or ALT 3 times above the upper limit of the range of normality, or levels of total bilirubin 2 times above the upper limit of the range
- •Advanced heart block (grade 2 or 3), unless paced
- •Uncontrolled hypotension
Outcomes
Primary Outcomes
Full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed
Full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed
Secondary Outcomes
- 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
Investigators
Nicola Disma
Scientific
Giannina Gaslini Institute For Scientific Hospitalization And Care
Study Sites (8)
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