Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
100
Countries
1
Sites
2
Elective surgery
The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 13 Jan 2025 → 5 Oct 2025
- Decision date (initial)
- 2024-11-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years.
Secondary objectives 5
- Intubating conditions assessed by IDS
- Intubating conditions assessed by Fuchs-Buder scale
- Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline)
- Change in mean arterial blood pressure from before induction to immediately after intubation
- Time to TOF 0.9
Conditions and MedDRA coding
Elective surgery
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A blinded randomized study of ephedrine for reducing onset time of rocuronium A blinded randomized study of ephedrine 0.15 mg/kg for reducing onset time of rocuronium 0.6 mg/kg in elderly patients (≥ 80 years)
|
Randomised Controlled | Single | [{"id":91087,"code":2,"name":"Investigator"}] | Ephedrine: Ephedrine 0.15 mg/kg Placebo: saline |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients ≥ 80 years old
- Informed consent
- Scheduled for elective surgery (expected duration of anesthesia >1 hour) under general anesthesia with intubation and use of rocuronium
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Can read and understand Danish
Exclusion criteria 5
- Known allergy to rocuronium or ephedrine
- Neuromuscular disease that may interfere with neuromuscular data
- Indication for rapid sequence induction
- Daily use of beta-blocking agents
- Known cardiac arrythmia (atrial fibrillation, supraventricular or ventricular)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to TOF 0 (from end of administration of rocuronium until TOF 0)
Secondary endpoints 5
- Intubating conditions assessed by IDS
- Intubating conditions assessed by Fuchs-Buder scale
- Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline)
- Change in mean arterial blood pressure from before induction to immediately after intubation
- Time to TOF 0.9
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ephedrine "Sintetica", injektionsvæske, opløsning 50 mg/ml
PRD9049285 · Product
- Active substance
- Ephedrine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA26 — -
- Marketing authorisation
- 62469
- MA holder
- SINTETICA GMBH
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Inge Lehmanns Vej 7
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Matias Vested
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Matias Vested
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000010857
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 100 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Anaesthesia GLO, Valdemar Hansens Vej 1-23, 2600, Glostrup
Rigshospitalet
Anaesthesia HOC, Blegdamsvej 9, 2100, Copenhagen Oe
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 | 2025-01-13 | 2025-10-05 | 2025-01-13 | 2025-10-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol Ephedrine for Rocuronium Onset CTIS | 7.0 |
| Recruitment arrangements (for publication) | Recruitment strategies | 1.1 |
| Subject information and informed consent form (for publication) | Deltagerinformation Efedrin | 1.1 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin maj 2023 | 1 |
| Subject information and informed consent form (for publication) | Samtykke ephedrin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Efedrin SAD injektionsvske oplsning 50 mg-ml | 1 |
| Synopsis of the protocol (for publication) | PROTOKOLRESUME | 1 |
| Synopsis of the protocol (for publication) | PROTOKOLRESUME rev | 2 |
| Synopsis of the protocol (for publication) | PROTOKOLRESUME rev chang | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-09 | Denmark | Acceptable 2024-11-08
|
2024-11-13 |