Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
10
Countries
1
Sites
1
General anesthesia
To investigate the duration and efficiency of rapid sequence emergence of general anaesthesia
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Not possible to specify
- Decision date (initial)
- 2025-12-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Radboudumc
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Efficacy
To investigate the duration and efficiency of rapid sequence emergence of general anaesthesia
Conditions and MedDRA coding
General anesthesia
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | WAYBACK intervention group 10 ASA 1/2 healthy males and females in the age group of 18-65 years
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- IPD will not be shared with anybody outside the study team. The study team consist of four anesthesiologist-researchers who will use IPD only for the purpose of this study. Will will use the data for the investigation of the study objectives and endpoints, and nothing else.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516415-24-01 | Rapid sequence emergence of general Anaesthesia | Stichting Radboud universitair medisch centrum |
| 2024-516415-24-00 | Rapid sequence emergence of general Anaesthesia | Stichting Radboud universitair medisch centrum |
| 2024-516415-24-02 | Rapid sequence emergence of general Anaesthesia | Stichting Radboud universitair medisch centrum |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age 18-65
- ASA ≤ II (no systemic diseases, including cardiac, pulmonary, liver and kidney diseas-es or epilepsy)
Exclusion criteria 8
- No informed consent
- Allergic reaction for one of the used agents
- Expected or known difficult airway
- BMI > 30
- Pregnancy (anamnestic or use of oral anticonceptives). One of the medicines we use (sugammadex) can temporarily increase the risk of pregnancy. This is equivalent to one missed pill
- ASA > II
- Systemic diseases or epilepsy
- Use of alcohol < 24 hr and drugs < 48 hr before start of the trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to the return of spontaneous breathing
Secondary endpoints 8
- Time to opening the eyes
- Time to return of airway reflexes (swallow-ing, coughing)
- Respiratory effects (saturation, respiratory rate, capnography)
- Hemodynamic effects (blood pressure, heart rate)
- Bispectral Index Score (BIS)
- Neuromuscular block depth
- Physician satisfaction
- Total time to emerge from anaesthesia (to-tally awake, as before induction)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SCP52642089 · ATC
- Active substance
- Remimazolam
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 33 mg milligram(s)
- Max total dose
- 33 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD14 — REMIMAZOLAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sufentanil Viatris 5 microgram/ml oplossing voor injectie
PRD10933530 · Product
- Active substance
- Sufentanil Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 5 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- BE308183
- MA holder
- VIATRIS GX
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Esmeron 10 mg/ml, oplossing voor injectie
PRD11366762 · Product
- Active substance
- Rocuronium Bromide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 2 mg/Kg milligram(s)/kilogram
- Max total dose
- 2 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AC09 — ROCURONIUM BROMIDE
- Marketing authorisation
- RVG 16946
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ANEXATE 0,5 mg/5 ml, solution injectable (I.V.)
PRD3965287 · Product
- Active substance
- Flumazenil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB25 — FLUMAZENIL
- Marketing authorisation
- 355 758-8
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Naloxon HCl Accord 0,4 mg/ml, oplossing voor injectie / infusie in een voorgevulde spuit
PRD10835140 · Product
- Active substance
- Naloxone Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 2 mg/Kg milligram(s)/kilogram
- Max total dose
- 2 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB15 — NALOXONE
- Marketing authorisation
- RVG 128182
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sugammadex hameln 100 mg/ml oplossing voor injectie
PRD11940849 · Product
- Active substance
- Sugammadex Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 16 mg/Kg milligram(s)/kilogram
- Max total dose
- 16 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB35 — -
- Marketing authorisation
- RVG 125851
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Rebecca Koch
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Rebecca Koch
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum / RADBOUDUMC
Anesthesiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol 2024-516415-24 clean | 1 |
| Protocol (for publication) | D1_protocol 2024-516415-24 track changes | 3 |
| Recruitment arrangements (for publication) | K1_recruitment procedure 2024-516415-24 clean version | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516415-24 clean version | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC flumazenil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC naloxone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC remimazolam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC rocuronium | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC sufentanil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC sugammadex | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis English | 1 |
| Synopsis of the protocol (for publication) | D1_synopsis_dutch_2024-516415-24 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-21 | Netherlands | Acceptable 2025-12-01
|
2025-12-02 |