Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
NCT Number: NCT06564857
Acronym: ROCVIDEO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Tracheal Intubation|Video Laryngoscopy|Remifentanil|Rocuronium
Interventions: DRUG: Remifentanil|DRUG: Rocuronium
Sponsor: Nordsjaellands Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2684
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-06-01
Completion Date: 2026-09-01

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.

Primary Outcome Measures: Proportion of participants with one or more intubation or anaesthesia related adverse events, Early (\< 10 min): Cardiac arrest; anaphylaxis; pulmonary aspiration of gastric content; serious traumatic airway injury; desaturation (SAT \< 90%); major hemodynamic instability (MAP \< 50, new onset bradycardia \< 40 beats/min); or sustained new arrhythmia (causing hemodynamic instability or requiring intervention).

Late (\< 24 h): Death; brain damage including stroke; acute myocardial infarction; ICU admission; re-intubation; respiratory failure (oxygen demand \> 5 l/min or requiring interventions aside from oxygen therapy); intraoperative awareness; pneumonia; dental injury; sore throat; or hoarseness., 0 minutes to 24 hours after administration of drugs for intubation|Proportion of participants with failed first-pass intubation, Defined as failed tracheal tube delivery after the first attempt of introduction of the video laryngoscope into the patient's mouth.

Tracheal tube delivery is defined as failed when the tube is retracted out of the patient's mouth, OR the video laryngoscope has to be retracted out of the patient's mouth, OR there is a shift in intubation equipment OR a change in the person performing the intubation management OR the intubation is abandoned., Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
Secondary Outcome Measures: Lengths of stay at the Post-Anaesthesia Care Unit., Minutes the patient is at the Post-Anaesthesia Care Unit., 0-48 hours postoperatively
Other Outcome Measures: Proportion of participants with failed intubation, The intubation is abandoned, 2 to 20 minutes after administration of drugs for intubation|Number of intubation attempts, The first attempt is defined as an attempt (successful or not) at tracheal tube delivery after the first introduction of the video laryngoscope into the patient's mouth.

Additionally attempts are defined as: when the tube has to be re-introduced into the patient's mouth, OR the videolaryngoscopy has to be re-introduced into the patient mouth, OR there is a shift in intubation equipment OR a change in the person performing the intubation management, 2 to 20 minutes after administration of drugs for intubation|Vocal cords position at first intubation attempt, Categorised as closed, intermediate or open, 2 to 20 minutes after administration of drugs for intubation|Proportion of participants with need for rescue medication or airway management, Rescue medication is defined as: An additional bolus of neuromuscular blocking agents, or bolus of opioid or propofol or other anesthetics according to the discretion of the attending anaesthesiologist in order to solve insufficient airway management conditions., 2 to 20 minutes after administration of drugs for intubation|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", As stated in the relevant outcome descriptions, 0 minutes to 7 days after administration of drugs for intubation|Proportion of participants with anaesthesia induction related grave desaturation, SAT \< 80%, 0 to 10 minutes after administration of drugs for intubation|Proportion of participants with anaesthesia induction related hypertension, MAP increase \> 30% at induction, 0 to 10 minutes after administration of drugs for intubation|Proportion of participants in need of vasoactive substances after induction, Defined as any vasoactive substance, e.g. epinephrine, noradrenaline, phenylephrine, ephedrine administrated as a response to severe hypotension or bradycardia after induction., 0 to 10 minutes after administration of drugs for intubation|Patient satisfaction score, The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied)), 24 hours after administration of drugs for intubation|Proportion of participants with one or more serious adverse events 0-7 days, Defined as: respiratory failure, major adverse cardiac (in-hospital all-cause death, acute myocardial infarction (AMI) both acute ST elevation MI and non-ST elevation MI, complete heart block, cardiogenic shock, cardiac arrhythmia and cardiac arrest), pneumonia, acute kidney injury, admission to ICU and cerebrovascular event (ischemic stroke including transient cerebral ischemia)., 0 minutes to 7 days after administration of drugs for intubation