Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
- Conditions
- RemifentanilTracheal IntubationVideo LaryngoscopyRocuronium
- Interventions
- Registration Number
- NCT06564857
- Lead Sponsor
- Nordsjaellands Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2684
- Adults > 18 years
- Undergoing general anaesthesia requiring oro-tracheal intubation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REMI-arm Remifentanil Bolus of remifentanil at anaesthesia induction ROCU-arm Rocuronium Bolus of rocuronium at anaesthesia induction
- Primary Outcome Measures
Name Time Method Proportion of participants with failed first-pass intubation Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil. 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.Proportion of participants with one or more intubation or anaesthesia related adverse events 0 minutes to 24 hours after administration of drugs for intubation 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.
- Secondary Outcome Measures
Name Time Method Lengths of stay at the Post-Anaesthesia Care Unit. 0-48 hours postoperatively Minutes the patient is at the Post-Anaesthesia Care Unit.