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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Anesthesiology, NOH, Rigshospitalet
RECRUITING
Copenhagen
Department of Anesthesiology, North Zeeland Hospital
RECRUITING
Hillerød
Contact Information
Primary
Anders K Nørskov, PhD
anders.kehlet.noerskov@regionh.dk
48292510
Backup
Lars H Lundstrøm, PhD
lars.hyldborg.lundstroem.02@regionh.dk
48296512
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2027-04-08
Participants
Target number of participants: 2648
Treatments
Experimental: REMI-arm
Bolus of remifentanil at anaesthesia induction
Active_comparator: ROCU-arm
Bolus of rocuronium at anaesthesia induction
Sponsors
Leads: Nordsjaellands Hospital

This content was sourced from clinicaltrials.gov