Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06564857

Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

Led by Nordsjaellands Hospital · Updated on 2025-12-10

2648

Participants Needed

2

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Scheduled for general anaesthesia requiring oro-tracheal intubation
  • No indication for rapid sequence induction
  • American Society of Anesthesiologists (ASA) physical status score I to III
Not Eligible

You will not qualify if you...

  • Known allergy or contraindication to rocuronium or remifentanil (e.g., neuromuscular disease)
  • Awake intubation
  • Use of double-lumen endotracheal tube
  • Undergoing oral, pharyngeal, or laryngeal surgery
  • Surgical contraindication for neuromuscular blocking agents (e.g., nerve stimulator use)
  • Pregnant or breastfeeding
  • Unable to understand Danish or provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Department of Anesthesiology, NOH, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

2

Department of Anesthesiology, North Zeeland Hospital

Hillerød, Denmark, 3400

Actively Recruiting

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Research Team

A

Anders K Nørskov, PhD

CONTACT

L

Lars H Lundstrøm, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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