Acta anaesthesiologica Scandinavica · 2026
Remifentanil Versus Rocuronium for Optimising Video Laryngoscopy Assisted Tracheal Intubation-The ROCVIDEO Trial Protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Ipsen Emil Ørskov, Lundstrøm Lars Hyldborg, Lodenius Åse, Fisker Gustav, Hovind Magnus Fuhr, Nielsen Christian Lindgren, Oskarsdottir Hrund, Strøm Camilla, Rosenstock Charlotte Vallentin, Madsen Karl Peter Damgård, Wichmann Sine, Afshari Arash, Andersen Jacob Hessel, Nedergaard Helene Korvenius, Bill Louise, Cronhjort Maria, Mathiesen Ole, Jakobsen Janus Christian, Vested Matias, Nørskov Anders Kehlet
Аннотация
BACKGROUND: Routine use of neuromuscular blocking agents (NMBAs) is widely recommended to facilitate tracheal intubation. However, NMBA use is associated with potential adverse effects, including postoperative respiratory complications, intraoperative awareness and anaphylaxis. Bolus remifentanil is an alternative, but evidence supporting its effectiveness on first-pass success when using video laryngoscopy is sparse. We hypothesise that rocuronium reduces failed first-pass and the risk of induction- or airway-management-related complications compared with bolus remifentanil when using a video laryngoscope.
METHODS: ROCVIDEO is a Danish-Swedish, blinded, randomised, controlled trial comparing rocuronium (0.6 mg/kg) with remifentanil (4 μg/kg) at anaesthesia induction for facilitating orotracheal intubation using video laryngoscopy. Eligible adult participants (ASA-class I-III) undergoing general anaesthesia with video laryngoscopy-assisted orotracheal intubation will be randomised to rocuronium or remifentanil in a ratio of 1:1. Anaesthesia will be induced with propofol and optional fentanyl or sufentanil. Intubation will be initiated 120 s after administration of trial medicine. The two co-primary outcomes are: (I) anaesthesia-related adverse events and (II) failed first-pass intubation. Secondary outcomes include patient satisfaction, length of stay in the post anaesthesia care unit and serious adverse events. The trial will randomise 2684 participants to be able to detect a 30% relative risk reduction in failed first pass intubation and anaesthesia-related adverse events, with corresponding power of 80% and 99%, respectively, using a two-sided α of 0.025.
PERSPECTIVES: Given the global volume of tracheal intubation, even small differences may have substantial clinical implications. ROCVIDEO will generate high-quality evidence to inform future guidelines aiming to improve global clinical practice.
STATUS: As of 15 June 2026, the trial has randomised 707 participants across 15 sites. Recruitment is expected to be completed in the third quarter of 2027.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06564857; EUClinicalTrials.eu: 2025-521405-40-01.
METHODS: ROCVIDEO is a Danish-Swedish, blinded, randomised, controlled trial comparing rocuronium (0.6 mg/kg) with remifentanil (4 μg/kg) at anaesthesia induction for facilitating orotracheal intubation using video laryngoscopy. Eligible adult participants (ASA-class I-III) undergoing general anaesthesia with video laryngoscopy-assisted orotracheal intubation will be randomised to rocuronium or remifentanil in a ratio of 1:1. Anaesthesia will be induced with propofol and optional fentanyl or sufentanil. Intubation will be initiated 120 s after administration of trial medicine. The two co-primary outcomes are: (I) anaesthesia-related adverse events and (II) failed first-pass intubation. Secondary outcomes include patient satisfaction, length of stay in the post anaesthesia care unit and serious adverse events. The trial will randomise 2684 participants to be able to detect a 30% relative risk reduction in failed first pass intubation and anaesthesia-related adverse events, with corresponding power of 80% and 99%, respectively, using a two-sided α of 0.025.
PERSPECTIVES: Given the global volume of tracheal intubation, even small differences may have substantial clinical implications. ROCVIDEO will generate high-quality evidence to inform future guidelines aiming to improve global clinical practice.
STATUS: As of 15 June 2026, the trial has randomised 707 participants across 15 sites. Recruitment is expected to be completed in the third quarter of 2027.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06564857; EUClinicalTrials.eu: 2025-521405-40-01.