Clinical trial • Not applicable • Other

Remifentanil hydrochloride for Tracheal intubation during general anaesthesia (video laryngoscopy)

Not applicable trial of Remifentanil hydrochloride for Tracheal intubation during general anaesthesia (video laryngoscopy).

Overview

Trial Therapeutic Area
Other
Trial Disease
Tracheal intubation during general anaesthesia (video laryngoscopy)
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-06-2025
First CTIS Authorization Date
22-09-2025

Trial design

Randomised, rocuronium fresenius kabi (comparator) — rocuronium bromide; product information indicates intravenous bolus use with maximum total dose 0.6 mg/kg (as provided in product data).-controlled Not applicable trial across 19 sites in Denmark.

Randomised
Yes
Comparator
Rocuronium Fresenius Kabi (Comparator) — rocuronium bromide; product information indicates intravenous bolus use with maximum total dose 0.6 mg/kg (as provided in product data).
Target Sample Size
2684

Eligibility

Recruits 2684 No vulnerable population selected. The trial is limited to adults (≥18 years). Patients who do not understand Danish or are unable to give informed consent are explicitly excluded; informed consent from the participant is required..

Vulnerable Population
No vulnerable population selected. The trial is limited to adults (≥18 years). Patients who do not understand Danish or are unable to give informed consent are explicitly excluded; informed consent from the participant is required.

Inclusion criteria

  • {"criterion_text":"-\tAdults ≥ 18 years"}
  • {"criterion_text":"-\tUndergoing general anaesthesia requiring oro-tracheal intubation"}
  • {"criterion_text":"-\tAbsence of indication for rapid sequence induction"}
  • {"criterion_text":"-\tAmerican Society of Anesthesiologists (ASA) physical status score I - III"}

Exclusion criteria

  • {"criterion_text":"-\tKnown allergies or contraindications to rocuronium (e.g. neuromuscular disease) or remifentanil"}
  • {"criterion_text":"-\tAwake intubation"}
  • {"criterion_text":"-\tDouble-lumen endotracheal tube"}
  • {"criterion_text":"-\tOral, pharyngeal, and laryngeal surgery"}
  • {"criterion_text":"-\tSurgical contraindication for NMBAs (e.g. use of nerve stimulator)"}
  • {"criterion_text":"-\tPatients who do not understand Danish or are unable to give informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-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","definition_or_measurement_approach":"Composite of one or more intubation- or anaesthesia-related adverse events occurring in defined time windows: early events within <20 minutes and late events within <24 hours; specific events listed in the endpoint description will be recorded and counted."}
  • {"endpoint_text":"-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.","definition_or_measurement_approach":"Prevalence (proportion) of failed first-pass intubation; failure defined as inability to deliver the tracheal tube after the first attempt to introduce the video laryngoscope into the patient's mouth."}

Recruitment

Planned Sample Size
2684
Recruitment Window Months
15
Consent Approach
Informed consent from participants is required. The trial includes subject information and informed consent form documents; participants must be able to understand Danish and provide consent (patients who do not understand Danish or are unable to give informed consent are excluded). No details on assent or additional age-specific documents provided.

Geography

Total Number Of Sites
19
Total Number Of Participants
2684

Denmark

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
179
Number Of Sites
19
Number Of Participants
2684

Sites

Site Name
Region Sjaelland
Department Name
Anaesthesiology
Contact Person Name
Jakob Hessel Andersen
Contact Person Email
jahea@regionsjaelland.dk
Site Name
Rigshospitalet
Department Name
Department of Anesthesia Centre of Head and Orthopedics
Contact Person Name
Matias Vedsted
Contact Person Email
Matias.vested@regionh.dk
Site Name
Region Midtjylland
Department Name
Anaesthesiology
Contact Person Name
Christoffer Grant Sølling
Contact Person Email
chrisl@rm.dk
Site Name
Region Syddanmark
Department Name
Anaesthesiology
Contact Person Name
Jesper Kampp Holm
Contact Person Email
Jesper.Kampp.Holm@rsyd.dk
Site Name
Region Syddanmark
Department Name
Anaesthesiology
Contact Person Name
Christopher Garcia
Contact Person Email
christopher.garcia@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Anaesthesiology
Contact Person Name
Anders Kehlet Nørskov
Site Name
Aalborg University Hospital
Department Name
Anaesthesiology
Contact Person Name
Jannie Bisgaard Stæhr
Contact Person Email
j.staehr@rn.dk
Site Name
Region Midtjylland
Department Name
Anaesthesiology
Contact Person Name
Anne Cathrine Haug
Contact Person Email
ANCHAU@rm.dk
Site Name
Region Midtjylland
Department Name
Anaesthesiology
Contact Person Name
Christian Jessen
Contact Person Email
chijss@rm.dk
Site Name
Rigshospitalet
Department Name
Anaesthesiology
Contact Person Name
Fabio Rosa
Contact Person Email
fabio.rosa@regionh.dk
Site Name
Region Sjaelland
Department Name
Anaesthesiology
Contact Person Name
Thea Palsgaard Møller
Contact Person Email
thea@regionsjaelland.dk
Site Name
Region Hovedstaden
Department Name
Anaesthesiology
Contact Person Name
Troels Haxholdt Lunn
Site Name
Region Midtjylland
Department Name
Anaesthesiology
Contact Person Name
Rikke Mærkedahl
Contact Person Email
rikmae@rm.dk
Site Name
Rigshospitalet
Department Name
Department: Department of Anaesthesiology, Centre for Cancer and Organ Diseases
Contact Person Name
Robin Lohse
Contact Person Email
robin.lohse@regionh.dk
Site Name
Region Syd
Department Name
Anaesthesiology
Contact Person Name
Helene Korvenius Nedergaard
Site Name
Region Syd
Department Name
Anaesthesiology
Contact Person Name
Nick Phaff Steen
Contact Person Email
nick.phaff.steen@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Anaesthesiology
Contact Person Name
Kim Wildgaard
Contact Person Email
Kim.wildgaard@regionh.dk
Site Name
Region Midtjylland
Department Name
Anaesthesiology
Contact Person Name
Jens Rolighed Larsen
Contact Person Email
Jenslase@rm.dk
Site Name
Rigshospitalet
Department Name
Dept. of Neuroanaesthesiology
Contact Person Name
Christine Sølling
Contact Person Email
Christine.soelling@regionh.dk

Sponsor

Primary sponsor

Full Name
Nordsjaellands Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"1","organisation_type":"Regulatory Authority"}

Investigational products

Investigational Product Name
Remifentanil Fresenius Kabi
Active Substance
Remifentanil hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
Intravenous bolus
Authorisation Status
Authorised (marketing authorisation number present: 43936)
Maximum Dose
4 µg/kg (max total dose amount as provided)
Investigational Product Name
Rocuronium Fresenius Kabi
Active Substance
Rocuronium bromide
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
Intravenous bolus
Authorisation Status
Authorised (marketing authorisation number present: 41406)
Maximum Dose
0.6 mg/kg (max total dose amount as provided)

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