Dexmedetomidine hydrochloride for General anaesthesia

Inclusion criteria

• {"criterion_text":"- Younger than 2 years old (chronological age)\n- 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\n- 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

• {"criterion_text":"- Known neurologic, chromosomal or congenital anomaly which is likely to be associated with poor neurobehavioural outcome\n- Previous adverse reaction to any anaesthetic\n- Circumstances likely to make long-term follow-up impossible\n- 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\n- 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\n- Known hypersensitivity to the study investigational medicinal products (IMPs) and their excipients\n- Renal impairment, defined as eGFR < 60 mL/min/1.73 m2, as calculated with Schwartz formula (eGFR = 0.5 × height (cm)/plasma creatinine)\n- 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\n- Advanced heart block (grade 2 or 3), unless paced\n- Uncontrolled hypotension\n- Acute cerebrovascular conditions\n- Existing diagnosis of behavioural or neurodevelopmental disability\n- Prematurity (defined as < 36 weeks gestational age at birth)\n- Birth weight less than 2 kg\n- Congenital cardiac disease requiring surgery\n- Intracranial neurosurgery and intracranial craniofacial surgery (isolated cleft lip is not an exclusion)\n- Previous cumulative exposure to general anaesthesia exceeding 2 hours\n- Planned future cumulative exposure to anaesthesia exceeding 2 hours before the age of 3 years.\n- Any specific contra-indication to any aspect of the protocol."}

Primary endpoints

• {"endpoint_text":"- Full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed","definition_or_measurement_approach":"Full scale IQ score measured using the Wechsler Preschool and Primary School Intelligence Scale, assessed at 3 years of age."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"A battery of neuropsychological assessments at 3 years of age using specified tests: TLV for language, NEPSY-2 subtests for attention/executive function and memory, Adaptive Behavior Assessment System for adaptive behaviour, Child Behavior Checklist for clinical behaviour, Behavior Rating of Executive Function-Preschool for executive function."}
• {"endpoint_text":"- Anaesthesia - Incidence of intra-operative hypotension - Intra-operative bradycardia - Post-operative pain (FLACC Scale: Face, Legs, Activity, Cry, Consolability Scale) - Time to recovery","definition_or_measurement_approach":"Anaesthesia-related outcomes measured as incidence rates for intra-operative hypotension and bradycardia; postoperative pain assessed using the FLACC scale; time to recovery measured as time to clinical recovery (specific timepoint definition not provided)."}
• {"endpoint_text":"- Safety - Nature and incidence of adverse events and serious adverse events","definition_or_measurement_approach":"Safety monitoring of adverse events and serious adverse events with recording of nature and incidence (standard AE/SAE reporting)."}

Italy

Earliest CTIS Part Ii Submission Date

29-05-2024

Latest Decision Or Authorization Date

09-07-2024

Processing Time Days

41

Number Of Sites

8

Number Of Participants

150

Primary sponsor

Full Name

Giannina Gaslini Institute For Scientific Hospitalization And Care

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Contract research organisations

Name

Opera Contract Research Organization S.R.L.

Responsibilities

sponsorDuties code: 1; contact: adina.paulescu@tigermedgrp.com

Third parties

• {"country":"Romania","full_name":"Opera Contract Research Organization S.R.L.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"sponsorDuties codes: 12; 15 (TMF Management); 8","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Bambino Gesu Childrens Hospital","duties_or_roles":"sponsorDuties code: 15 (PK Analysis)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Australia","full_name":"Murdoch Children'S Research Institute","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Laboratory/Research/Testing facility"}