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Study aimed at comparing the impact on long-term neurocognitive development of the use of low dose sevoflurane, dexmedetomidine and remifentanil anaesthesia compared to current anaesthesia with standard dosage of sevoflurane
EU CTIS ID: 2024-512385-34-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.)
You likely can't join if
- 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
See the full eligibility 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.)
- 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
- Acute cerebrovascular conditions
- Existing diagnosis of behavioural or neurodevelopmental disability
- Prematurity (defined as < 36 weeks gestational age at birth)
- Birth weight less than 2 kg
- Congenital cardiac disease requiring surgery
- Intracranial neurosurgery and intracranial craniofacial surgery (isolated cleft lip is not an exclusion)
- Previous cumulative exposure to general anaesthesia exceeding 2 hours
- Planned future cumulative exposure to anaesthesia exceeding 2 hours before the age of 3 years.
- Any specific contra-indication to any aspect of the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.