NCT06564857 Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
| NCT ID | NCT06564857 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nordsjaellands Hospital |
| Condition | Tracheal Intubation |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,648 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,648 participants in total. It began in 2025-11-17 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 * Absence of indication for rapid sequence induction * American Society of Anesthesiologists (ASA) physical status score I - III Exclusion Criteria: * Known allergies or contraindications to rocuronium (e.g. neuromuscular disease) or remifentanil * Awake intubation * Double-lumen endotracheal tube * Oral, pharyngeal, and laryngeal surgery * Surgical contraindication for NMBAs (e.g. use of nerve stimulator) * Patients who are pregnant or breastfeeding * Patients who do not understand Danish or are unable to give informed consent
Contact & Investigator
Anders K Nørskov, PhD
PRINCIPAL INVESTIGATOR
Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark
Frequently Asked Questions
Who can join the NCT06564857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tracheal Intubation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06564857 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06564857 currently recruiting?
Yes, NCT06564857 is actively recruiting participants. Contact the research team at anders.kehlet.noerskov@regionh.dk for enrollment information.
Where is the NCT06564857 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Hillerød, Denmark.
Who is sponsoring the NCT06564857 clinical trial?
NCT06564857 is sponsored by Nordsjaellands Hospital. The principal investigator is Anders K Nørskov, PhD at Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark. The trial plans to enroll 2,648 participants.