Clinical trial • Not applicable • Other
Rocuronium bromide for Craniosynostosis
Not applicable trial of Rocuronium bromide for Craniosynostosis.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Craniosynostosis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 04-07-2024
- First CTIS Authorization Date
- 03-09-2024
Trial design
open-label, rocuronium 0.6 mg/kg iv versus rocuronium 0.9 mg/kg iv; anaesthesia maintained with sevoflurane or propofol according to anaesthetist's judgement.-controlled Not applicable trial in Hungary.
- Open Label
- Yes
- Comparator
- Rocuronium 0.6 mg/kg IV versus Rocuronium 0.9 mg/kg IV; anaesthesia maintained with sevoflurane or propofol according to anaesthetist's judgement.
- Target Sample Size
- 20
- Trial Duration For Participant
- 1
Eligibility
Recruits 20 paediatric patients.
- Vulnerable Population
- Participants are infants aged 3-12 months; informed written consent must be provided by parents (legal guardians). No assent is applicable.
Inclusion criteria
- {"criterion_text":"- 20 infants whose parents have given informed written consent to participate in the studies;\n- Age: 3-12 months;"}
Exclusion criteria
- {"criterion_text":"- diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);\n- Lack of parental consent\n- Known allergy to any of the products used"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of both the first and second phase of the study is to investigate the extent to which sevoflurane used to maintain inhalational anaesthesia and propofol used to maintain total intravenous anaesthesia potentiate the pharmacokinetic properties of rocuronium at different doses. The translational clinical utility of this may be that knowledge in this age population will contribute to the safe implementation of reversal of muscle relaxant action.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 11
- Consent Approach
- Informed written consent provided by parents (legal guardians). Subject information and informed consent form is available (document listed). Assent not applicable due to participant age. Languages not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-08-2024
- Latest Decision Or Authorization Date
- 03-09-2024
- Processing Time Days
- 19
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- University Of Debrecen
- Department Name
- FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
- Principal Investigator Name
- Béla Fülesdi
- Principal Investigator Email
- fulesdi@med.unideb.hu
- Contact Person Name
- Béla Fülesdi
- Contact Person Email
- fulesdi@med.unideb.hu
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- University Of Debrecen
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Hungary
Investigational products
- Investigational Product Name
- Rocuronium bromide hameln 10 mg/ml solution for injection/infusion
- Active Substance
- Rocuronium bromide
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation number OGYI-T-23194/10)
- Starting Dose
- 0.6 mg/kg
- Dose Levels
- 0.6 mg/kg; 0.9 mg/kg
- Combination Treatment
- Yes
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