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Remifentanil contro rocuronio per ottimizzare l’intubazione tracheale assistita da laringoscopia video (ROCVIDEO)

16 settembre 2026 aggiornato da: Nordsjaellands Hospital

Remifentanil contro rocuronio per ottimizzare l'intubazione tracheale assistita da laringoscopia video in pazienti sottoposti ad anestesia generale: uno studio multicentrico randomizzato e controllato - Lo studio ROCVIDEO

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

2684

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Copenhagen, Danimarca, 2100
        • Reclutamento
        • Department of Anesthesiology, NOH, Rigshospitalet
        • Contatto:
      • Hillerød, Danimarca, 3400

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

Altri nomi:
  • Remifentanil 5 mg diluito in 100 ml di soluzione salina, che corrisponde a Remifentanil 50 microgrammi/ml
Comparatore attivo: ROCU-arm

Bolus of rocuronium at anaesthesia induction

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

Altri nomi:
  • Rocuronio 10 mg/ml

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with one or more intubation or anaesthesia related adverse events
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient satisfaction score
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 0-48 hours postoperatively

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

0-48 hours postoperatively

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with failed intubation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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"
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 novembre 2025

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

8 aprile 2027

Date di iscrizione allo studio

Primo inviato

25 giugno 2024

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2024

Primo Inserito (Effettivo)

21 agosto 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 ottobre 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ROCVIDEO
  • 2025-521405-40-01 (Ctis)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Anonymised data will be made available upon reasonable request

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

Anonymised data will be made available upon reasonable request.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .