Overview
Sponsor-declared trial summary
Neonates (postmenstrual age below 47 weeks) undergoing general anesthesia for any condition
To establish the effective dose 50% for the anesthetics propofol and thiopental for intravenous induction of anesthesia in newborns below the postmenstrual age of 47 weeks.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 16 Jun 2022 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516072-15-00
- EudraCT number
- 2019-001534-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
To establish the effective dose 50% for the anesthetics propofol and thiopental for intravenous induction of anesthesia in newborns below the postmenstrual age of 47 weeks.
Secondary objectives 1
- To document the respiratory and hemodynamic effects of induction doses of propofol and thiopental
Conditions and MedDRA coding
Neonates (postmenstrual age below 47 weeks) undergoing general anesthesia for any condition
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Neonates <47 weeks postmenstrual age (PMA) undergoing general anesthesia (GA) for any condition
Exclusion criteria 1
- 1. Allergies towards propofol or thiopental, 2. Known or family history of porphyria (thiopental only), 3. Parental refusal of insertion of an iv-line., 4. sedation within last 24 hours, 5. Contraindication to propofol or thiopental according to the attending anesthesiologist, not mentioned above.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Loss of eyelash reflex and acceptance of facemask
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione.
PRD2036438 · Product
- Active substance
- Propofol
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 3 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 035911054
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tiomebumalnatrium SAD, injektionsvæske, opløsning
PRD343697 · Product
- Active substance
- Thiopental Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AF03 — THIOPENTAL
- Marketing authorisation
- 16534
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Kristian Nørholm Jensen
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Kristian Nørholm Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 160 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2022-06-16 | 2022-11-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_2024-516072-15-00 | 1.4 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_ICF For parents and guardians | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS for parents and guardians | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Propofol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Thiopental | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_DK 2024-516072-15-00 | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | Denmark | Acceptable 2024-10-17
|
2024-10-23 |