Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation (ROCVIDEO)

Nordsjaellands Hospital

Status and phase: Enrolling; Phase 4

Conditions: Tracheal Intubation; Video Laryngoscopy; Remifentanil; Rocuronium

Treatments: Drug: Remifentanil; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT06564857

ROCVIDEO

2025-521405-40-01 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 2,648 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,648 participants in 2 patient groups

REMI-arm

Experimental group

Description:

Bolus of remifentanil at anaesthesia induction

Treatment:

Drug: Remifentanil

ROCU-arm

Active Comparator group

Description:

Bolus of rocuronium at anaesthesia induction

Treatment:

Drug: Rocuronium