Clinical trial NCT06564857: Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
Official title: Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Tracheal Intubation
Video Laryngoscopy
Remifentanil
Rocuronium
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 2684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, multicenter
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years
* Undergoing general anaesthesia requiring oro-tracheal intubation

Exclusion Criteria:

* Neuromuscular disease that may interfere with neuromuscular monitoring
* Awake intubation
* Rapid sequence induction
* Known allergies or contraindications to rocuronium or remifentanil
* Patients who do not understand Danish or English or are unable to give informed consent.
* Oral, pharyngeal, and laryngeal surgery
* Surgical indication for the use of a nerve stimulator

Primary outcomes:
measure: Proportion of participants with one or more intubation or anaesthesia related adverse events
timeFrame: 0 minutes to 24 hours after administration of drugs for intubation
measure: Proportion of participants with failed first-pass intubation
timeFrame: Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
Secondary outcomes:
measure: Lengths of stay at the Post-Anaesthesia Care Unit.
timeFrame: 0-48 hours postoperatively
Other outcomes:
measure: Proportion of participants with failed intubation
timeFrame: 2 to 20 minutes after administration of drugs for intubation
measure: Number of intubation attempts
timeFrame: 2 to 20 minutes after administration of drugs for intubation
measure: Vocal cords position at first intubation attempt
timeFrame: 2 to 20 minutes after administration of drugs for intubation
measure: Proportion of participants with need for rescue medication or airway management
timeFrame: 2 to 20 minutes after administration of drugs for intubation
measure: 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"
timeFrame: 0 minutes to 7 days after administration of drugs for intubation
measure: Proportion of participants with anaesthesia induction related grave desaturation
timeFrame: 0 to 10 minutes after administration of drugs for intubation
measure: Proportion of participants with anaesthesia induction related hypertension
timeFrame: 0 to 10 minutes after administration of drugs for intubation
measure: Proportion of participants in need of vasoactive substances after induction
timeFrame: 0 to 10 minutes after administration of drugs for intubation
measure: Patient satisfaction score
timeFrame: 24 hours after administration of drugs for intubation
measure: Proportion of participants with one or more serious adverse events 0-7 days
timeFrame: 0 minutes to 7 days after administration of drugs for intubation
Locations:
Study officials:
affiliation: Nordsjællands Hospital, Anæstesiologisk afdeling; Denmark
name: Anders K Nørskov, PhD
role: PRINCIPAL_INVESTIGATOR
References: