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Remifentanil versus Rocuronium for optimalisering av video laryngoskopi-assistert trakeal intubasjon (ROCVIDEO)

16. september 2026 oppdatert av: Nordsjaellands Hospital

Remifentanil versus Rocuronium for optimalisering av video-laryngoskopi-assistert trakeal intubasjon hos pasienter som gjennomgår generell anestesi - et multisenter randomisert kontrollert forsøk - ROCVIDEO-forsøket

Globally, we are approaching 1 million surgical procedures each day. Tracheal intubation is the mainstay of securing the patient's airway and breathing during general anaesthesia. Approximately 100.000 tracheal intubations are performed annually in Denmark. Airway management remains the primary reason for anaesthesia-related morbidity and mortality. It has been traditionally accepted that best tracheal intubation conditions are obtained by paralysing the patient's muscles, including vocal cords, using a neuromuscular blocking agent (NMBA) such as rocuronium. However, using NBMA may increase the risk of pulmonary complications, intra-operative awareness, in which the patient is paralysed but awake during surgery, anaphylaxis, and re-intubation. In addition, there is a risk of residual neuromuscular blockade postoperatively. In the US, prolonged ventilation and unplanned intubation are the top two most costly perioperative complications. An alternative to NMBA is a large dose of opioids to depress laryngeal reflexes during intubation. The most commonly used non-NMBA modality includes bolus administration of remifentanil. However, remifentanil may cause bradycardia and hypotension. Even short periods of hypotension have been shown to increase the risk of myocardial injury and other serious adverse events such as renal failure, delirium, and even mortality.

Evidence also indicates that intubation conditions using only opioids to facilitate intubation, including remifentanil, are inferior to NMBA. However, these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias. A recent trial has suggested that remifentanil intubation conditions may not be very different. Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade. In recent years, the implementation and availability of the video laryngoscope have grown exponentially and become universal. The video laryngoscope has vastly improved the ease of tracheal intubation, and the number of failed intubations has decreased by two-thirds in Denmark, where a rapid implementation of the video laryngoscope took place. However, limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

2684

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Copenhagen, Danmark, 2100
        • Rekruttering
        • Department of Anesthesiology, NOH, Rigshospitalet
        • Ta kontakt med:
      • Hillerød, Danmark, 3400

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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:

  • 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 are pregnant or breastfeeding
  • Patients who do not understand Danish or are unable to give informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: REMI-arm

Bolus of remifentanil at anaesthesia induction

Age < 70 years: Bolus of 4 μg/kg Ideal Body Weight remifentanil at anaesthesia induction; Age >= 70 years: Bolus of 2 μg/kg ideal Body Weight remifentanil at anaesthesia induction

Andre navn:
  • Remifentanil 5 mg fortynnet i 100 ml saltvann, som tilsvarer Remifentanil 50 mikrogram/ml
Aktiv komparator: ROCU-arm

Bolus of rocuronium at anaesthesia induction

Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction

Andre navn:
  • Rocuronium 10 mg/ml

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants with one or more intubation or anaesthesia related adverse events
Tidsramme: 0 minutes to 24 hours after administration of drugs for intubation

Early (< 10 min): Cardiac arrest; anaphylaxis; pulmonary aspiration of gastric content; serious traumatic airway injury; desaturation (SAT < 90%); major hemodynamic instability (MAP < 50, new onset bradycardia < 40 beats/min); or sustained new arrhythmia (causing hemodynamic instability or requiring intervention).

Late (< 24 h): Death; brain damage including stroke; acute myocardial infarction; ICU admission; re-intubation; respiratory failure (oxygen demand > 5 l/min or requiring interventions aside from oxygen therapy); intraoperative awareness; pneumonia; dental injury; sore throat; or hoarseness.

0 minutes to 24 hours after administration of drugs for intubation
Proportion of participants with failed first-pass intubation
Tidsramme: Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.

Defined as failed tracheal tube delivery after the first attempt of introduction of the video laryngoscope into the patient's mouth.

Tracheal tube delivery is defined as failed when the tube is retracted out of the patient's mouth, OR the video laryngoscope has to be retracted out of the patient's mouth, OR there is a shift in intubation equipment OR a change in the person performing the intubation management OR the intubation is abandoned.

Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient satisfaction score
Tidsramme: 24 hours after administration of drugs for intubation

The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))

24 hours after administration of drugs for intubation
Proportion of participants with one or more serious adverse events 0-7 days
Tidsramme: 0 minutes to 7 days after administration of drugs for intubation

Defined as: respiratory failure, major adverse cardiac (in-hospital all-cause death, acute myocardial infarction (AMI) both acute ST elevation MI and non-ST elevation MI, complete heart block, cardiogenic shock, cardiac arrhythmia and cardiac arrest), pneumonia, acute kidney injury, admission to ICU and cerebrovascular event (ischemic stroke including transient cerebral ischemia).

0 minutes to 7 days after administration of drugs for intubation
Lengths of stay at the Post-Anaesthesia Care Unit.
Tidsramme: 0-48 hours postoperatively

Minutes the patient is at the Post-Anaesthesia Care Unit.

0-48 hours postoperatively

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants with failed intubation
Tidsramme: 2 to 20 minutes after administration of drugs for intubation

The intubation is abandoned

2 to 20 minutes after administration of drugs for intubation
Number of intubation attempts
Tidsramme: 2 to 20 minutes after administration of drugs for intubation

The first attempt is defined as an attempt (successful or not) at tracheal tube delivery after the first introduction of the video laryngoscope into the patient's mouth.

Additionally attempts are defined as: when the tube has to be re-introduced into the patient's mouth, OR the videolaryngoscopy has to be re-introduced into the patient mouth, OR there is a shift in intubation equipment OR a change in the person performing the intubation management

2 to 20 minutes after administration of drugs for intubation
Vocal cords position at first intubation attempt
Tidsramme: 2 to 20 minutes after administration of drugs for intubation

Categorised as closed, intermediate or open

2 to 20 minutes after administration of drugs for intubation
Proportion of participants with need for rescue medication or airway management
Tidsramme: 2 to 20 minutes after administration of drugs for intubation

Rescue medication is defined as: An additional bolus of neuromuscular blocking agents, or bolus of opioid or propofol or other anesthetics according to the discretion of the attending anaesthesiologist in order to solve insufficient airway management conditions.

2 to 20 minutes after administration of drugs for intubation
Proportion of participants with anaesthesia induction related grave desaturation
Tidsramme: 0 to 10 minutes after administration of drugs for intubation

SAT < 80%

0 to 10 minutes after administration of drugs for intubation
Proportion of participants in need of vasoactive or chronotropic substances after induction
Tidsramme: 0 to 10 minutes after administration of drugs for intubation

Defined as any vasoactive substance, e.g. epinephrine, noradrenaline, phenylephrine, ephedrine administrated as a response to severe hypotension or bradycardia after induction.

0 to 10 minutes after administration of drugs for intubation
Individual components of the composite outcomes "Proportion of participants with one or more intubation or anaesthesia related adverse events" and "Proportion of participants with one or more serious adverse events 0-7 days"
Tidsramme: 0 minutes to 7 days after administration of drugs for intubation

As stated in the relevant outcome descriptions

0 minutes to 7 days after administration of drugs for intubation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Anders K Nørskov, PhD, Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark
  • Hovedetterforsker: Matias Vested, PhD, Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. november 2025

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

8. april 2027

Datoer for studieregistrering

Først innsendt

25. juni 2024

Først innsendt som oppfylte QC-kriteriene

19. august 2024

Først lagt ut (Faktiske)

21. august 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. oktober 2025

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymised data will be made available upon reasonable request

IPD-delingstidsramme

The protocol is submitted prior to first randomisation. A comprehensive statistical analysis plan, including pre-specified subgroup analysis will be published before the final participant is enrolled.

Other material will be made available <12 months after trial cessation

Tilgangskriterier for IPD-deling

Anonymised data will be made available upon reasonable request.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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