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Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

Study acronym: ROCVIDEO
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Minor Enrollment target: 2648 to 2684
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Publications: details revised at 1 of 1 entry
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Jun 1, 2026 to Apr 1, 2027
    • Start date changed from estimate of Jun 1, 2025 to Nov 17, 2025
    • Enrollment target: 2684 to 2648
    • Study sites: 0 to 2
    • Study completion date: Sep 1, 2026 to Apr 8, 2027
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 1 to 3
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06564857
Lead Sponsor Nordsjaellands Hospital
Conditions
(from sponsor)
Tracheal Intubation, Video Laryngoscopy, Remifentanil, Rocuronium
Enrollment 2,684 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov