Overview
Sponsor-declared trial summary
a prospective, case-controlled study
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 clini…
Key facts
- Sponsor
- University Of Debrecen
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Not possible to specify
- Decision date (initial)
- 2024-09-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University of Debrecen Departnent of Anesthesiology and Intensive Care Unit
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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.
Conditions and MedDRA coding
a prospective, case-controlled study
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Measuring of the duration of action of different doses of rocuronium-induced neuromuscular block Measuring of the duration of action of different doses of rocuronium-induced neuromuscular block in infants during surgical treatment of craniosynostosis - a prospective, case-controlled study
|
2 | None | rocuronim 0,6 mg/kg: Depending on the anaesthetist's judgement - whether the infant is expected to have difficult breathing based on anthropological features - the infant is relaxed with either 0.6 mg/kg bw rocuronium (no difficult breathing expected) or 0.9 mg/kg bw rocuronium (difficult breathing expected). 0,9 mg/kg rocuronium: Depending on the anaesthetist's judgement - whether the infant is expected to have difficult breathing based on anthropological features - the infant is relaxed with either 0.6 mg/kg bw rocuronium (no difficult breathing expected) or 0.9 mg/kg bw rocuronium (difficult breathing expected). Anesthesia is maintabnced with propofol or sevoflurane. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - 20 infants whose parents have given informed written consent to participate in the studies; - Age: 3-12 months;
Exclusion criteria 1
- - diseases affecting neuromuscular function (myopathies, severe liver and kidney failure); - Lack of parental consent - Known allergy to any of the products used
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Rocuronium bromide hameln 10 mg/ml oldatos injekció/infúzió
PRD5591461 · Product
- Active substance
- Rocuronium Bromide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20250 mg/kg milligram(s)/kilogram
- Max total dose
- 1000 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AC09 — ROCURONIUM BROMIDE
- Marketing authorisation
- OGYI-T-23194/10
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Debrecen
- Sponsor organisation
- University Of Debrecen
- Address
- Nagyerdei Korut 98
- City
- Debrecen
- Postcode
- 4032
- Country
- Hungary
Scientific contact point
- Organisation
- University Of Debrecen
- Contact name
- Fülesdi Béla
Public contact point
- Organisation
- University Of Debrecen
- Contact name
- Fülesdi Béla
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | English protokoll | 1 |
| Protocol (for publication) | Protokoll alairasi oldal | 1 |
| Protocol (for publication) | Tablazat Cranio study | 1 |
| Protocol (for publication) | Vizsgalati terv | 1 |
| Recruitment arrangements (for publication) | Recriument arrangements | 1 |
| Subject information and informed consent form (for publication) | Betegtajekoztato es beleegyezo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | smpc rocuronium | 1 |
| Synopsis of the protocol (for publication) | Szinopszis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | Hungary | Acceptable 2024-08-22
|
2024-09-03 |