Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNordsjaellands Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known allergies or contraindications to rocuronium (e.g. neuromuscular disease) or remifentanil
Awake intubation
Double-lumen endotracheal tube
Oral, pharyngeal, and laryngeal surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Remifentanil
DrugAge \< 70 years: Bolus of 4 μg/kg Ideal Body Weight remifentanil at anaesthesia induction; Age \>= 70 years: Bolus of 2 μg/kg ideal Body Weight remifentanil at anaesthesia induction
Rocuronium
DrugBolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction
Treatment groups
2,684 Participants
are divided into 2 treatment groupsGroup A: REMI-armExperimental treatment 1 intervention
Group B: ROCU-armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
0 minutes to 24 hours after administration of drugs for intubation2
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.
Time frame
Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.Secondary outcomes
1
Patient satisfaction score
The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))
Time frame
24 hours after administration of drugs for intubation2
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).
Time frame
0 minutes to 7 days after administration of drugs for intubation3
Lengths of stay at the Post-Anaesthesia Care Unit.
Minutes the patient is at the Post-Anaesthesia Care Unit.
Time frame
0-48 hours postoperativelyOther outcomes
1
Proportion of participants with failed intubation
The intubation is abandoned
Time frame
2 to 20 minutes after administration of drugs for intubation2
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
Time frame
2 to 20 minutes after administration of drugs for intubation3
Vocal cords position at first intubation attempt
Categorised as closed, intermediate or open
Time frame
2 to 20 minutes after administration of drugs for intubation4
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.
Time frame
2 to 20 minutes after administration of drugs for intubationSponsors and contacts
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Source ClinicalTrials.gov