Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
2,684
Countries
1
Sites
19
Adult patients undergoing tracheal intubation using video laryngoscopy.
This trial aims to assess the benefits and harms of remifentanil versus rocuronium for optimising tracheal intubation conditions in adult patients undergoing tracheal intubation using video laryngoscopy.
Key facts
- Sponsor
- Nordsjaellands Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 12 Nov 2025 → ongoing
- Decision date (initial)
- 2025-09-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521405-40-01
- ClinicalTrials.gov
- NCT06564857
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
This trial aims to assess the benefits and harms of remifentanil versus rocuronium for optimising tracheal intubation conditions in adult patients undergoing tracheal intubation using video laryngoscopy.
Conditions and MedDRA coding
Adult patients undergoing tracheal intubation using video laryngoscopy.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521405-40-01 | Remifentanil versus rocuronium for optimizing video laryngoscopy assisted tracheal intubation in patients undergoing general anaesthesia - a multicentre randomised controlled trial The ROCVIDEO trial | Nordsjaellands Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Adults ≥ 18 years
- - Undergoing general anaesthesia requiring oro-tracheal intubation
- - Absence of indication for rapid sequence induction
- - American Society of Anesthesiologists (ASA) physical status score I - III
Exclusion criteria 6
- - Known allergies or contraindications to rocuronium (e.g. neuromuscular disease) or remifentanil
- - Awake intubation
- - Double-lumen endotracheal tube
- - Oral, pharyngeal, and laryngeal surgery
- - Surgical contraindication for NMBAs (e.g. use of nerve stimulator)
- - Patients who do not understand Danish or are unable to give informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Safety: A composite of one or more intubation or anaesthesia-related adverse events: Early (< 20 min): Cardiac arrest, anaphylaxis, pulmonary aspiration, serious traumatic airway injury, desaturation, major hemodynamic event, new onset bradycardia, sustained new arrhythmia Late (< 24 h): Death, brain damage including stroke, acute myocardial infarction, ICU admission, re-intubation, postoperative respiratory failure, intraoperative awareness, pneumonia, dental injury, sore throat, or hoarsenes
- Efficacy: Prevalence of failed first-pass intubation. Defined as failed tracheal tube delivery after the first attempt to introduce the video laryngoscope into the patient’s mouth.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1170144 · Product
- Active substance
- Remifentanil Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 4 µg/Kg microgram(s)/kilogram
- Max total dose
- 4 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH06 — REMIFENTANIL
- Marketing authorisation
- 43936
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD11873093 · Product
- Active substance
- Rocuronium Bromide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 0.6 mg/Kg milligram(s)/kilogram
- Max total dose
- 0.6 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AC09 — ROCURONIUM BROMIDE
- Marketing authorisation
- 41406
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nordsjaellands Hospital
- Sponsor organisation
- Nordsjaellands Hospital
- Address
- Dyrehavevej 29
- City
- Hilleroed
- Postcode
- 3400
- Country
- Denmark
Scientific contact point
- Organisation
- Nordsjaellands Hospital
- Contact name
- Lars Lundstrøm
Public contact point
- Organisation
- Nordsjaellands Hospital
- Contact name
- Lars Lundstrøm
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000005492
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 2,684 | 19 |
| Rest of world | — | 0 | — |
Investigational sites
Region Midtjylland
Anaesthesiology, Heibergs Alle 4, 8800, Viborg
Region Midtjylland
Anaesthesiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Hovedstaden
Anaesthesiology, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Region Midtjylland
Anaesthesiology, Falkevej 1/3, 8600, Silkeborg
Region Syddanmark
Anaesthesiology, Gl Vardevej 101, 6715, Esbjerg N
Region Midtjylland
Anaesthesiology, Sundvej 30, 8700, Horsens
Region Midtjylland
Anaesthesiology, Hospitalsparken 15, 7400, Herning
Region Syd
Anaesthesiology, Sygehusvej 24, 6000, Kolding
Region Syd
Anaesthesiology, Beridderbakken 4, 7100, Vejle
Region Syddanmark
Anaesthesiology, J.B. Winsloews Vej 16, 5000, Odense C
Region Sjaelland
Anaesthesiology, Smedelundsgade 60, 4300, Holbæk
Region Hovedstaden
Anaesthesiology, Herlev Ringvej 75, 2730, Herlev
Rigshospitalet
Anaesthesiology, Valdemar Hansens Vej 1-23, 2600, Glostrup
Rigshospitalet
Department of Anesthesia Centre of Head and Orthopedics, Blegdamsvej 9, 2100, Copenhagen Oe
Rigshospitalet
Department: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Blegdamsvej 9, 2100, Copenhagen Oe
Rigshospitalet
Dept. of Neuroanaesthesiology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Hovedstaden
Anaesthesiology, Kongens Vaenge 2, 3400, Hilleroed
Region Sjaelland
Anaesthesiology, Lykkebaekvej 1, 4600, Koege
Aalborg University Hospital
Anaesthesiology, Hobrovej 18-22, 9000, Aalborg
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 | 2025-11-12 | 2025-11-12 |
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) | Modified-Brice CTIS 2025-521405-40-01 | 1 |
| Protocol (for publication) | Protocol ROCVIDEO CTIS 2025-521405-40-01 | 2 |
| Protocol (for publication) | Protocol ROCVIDEO CTIS 2025-521405-40-01 RFI TC | 2 |
| Protocol (for publication) | QOR-15 CTIS 2025-521405-40-01 | 1 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure ROCVIDEO_2025-521405-40-01 | 2 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure ROCVIDEO_2025-521405-40-01_RFI TC | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation og Retigheder ROCVIDEO CTIS 2025-521405-40-01 | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation ROCVIDEO 2025-521405-40-01 v2 TC | 2 |
| Subject information and informed consent form (for publication) | Samtykkeerklring_ROCVIDEO_2025-521405-40-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Rocuronium SWE | 1 |
| Synopsis of the protocol (for publication) | The ROCVIDEO trial synopsis CTIS 2025-521405-40-01 | 2 |
| Synopsis of the protocol (for publication) | The ROCVIDEO trial synopsis v2 TC | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-21 | Denmark | Acceptable 2025-09-19
|
2025-09-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-06 | Denmark | Acceptable 2026-03-06
|
2026-03-06 |