Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

Официальное название

Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO Trial

Обзор

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.

Вмешательства

• Препарат Remifentanil
  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
• Препарат Rocuronium
  Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction

Первичные конечные точки

• Proportion of participants with one or more intubation or anaesthesia related adverse events [Срок оценки: 0 minutes to 24 hours after administration of drugs for intubation]
• Proportion of participants with failed first-pass intubation [Срок оценки: Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.]

Вторичные конечные точки (3)

• Patient satisfaction score [Срок оценки: 24 hours after administration of drugs for intubation]
• Proportion of participants with one or more serious adverse events 0-7 days [Срок оценки: 0 minutes to 7 days after administration of drugs for intubation]
• Lengths of stay at the Post-Anaesthesia Care Unit. [Срок оценки: 0-48 hours postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Department of Anesthesiology, NOH, Rigshospitalet — Copenhagen
• Department of Anesthesiology, North Zeeland Hospital — Hillerød

Публикации

• Ipsen EO, Lundstrom LH, Lodenius A, Fisker G, Hovind MF, Nielsen CL, Oskarsdottir H, Strom C, Rosenstock CV, Madsen KPD, Wichmann S, Afshari A, Andersen JH, Nedergaard HK, Bill L, Cronhjort M, Mathiesen O, Jakobsen JC, Vested M, Norskov AK. Remifentanil Versus Rocuronium for Optimising Video Laryngoscopy Assisted Tracheal Intubation-The ROCVIDEO Trial Protocol. Acta Anaesthesiol Scand. 2026 Jul;70 PMID 42304626

Идентификаторы

NCT: NCT06564857 · ROCVIDEO · 2025-521405-40-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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