Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

NCT ID: NCT06564857

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2648 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2027-04-08

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.

Conditions

Tracheal Intubation; Video Laryngoscopy; Remifentanil; Rocuronium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

REMI-arm

Bolus of remifentanil at anaesthesia induction

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

Age \< 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

ROCU-arm

Bolus of rocuronium at anaesthesia induction

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction

Interventions

Remifentanil

Age \< 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

Intervention Type: DRUG

Rocuronium

Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction

Intervention Type: DRUG

Other Intervention Names

Remifentanil 5 mg diluted in 100 ml saline, which corresponds to Remifentanil 50 micrograms/ml; Rocuronium 10 mg/ml

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders K Nørskov, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark

Matias Vested, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen

Locations

Department of Anesthesiology, NOH, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Department of Anesthesiology, North Zeeland Hospital

Hillerød, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anders K Nørskov, PhD

Role: CONTACT

anders.kehlet.noerskov@regionh.dk

48292510 ext. +45

Lars H Lundstrøm, PhD

Role: CONTACT

lars.hyldborg.lundstroem.02@regionh.dk

48296512 ext. +45

Facility Contacts

Matias Vedsted, MD, PhD

Role: primary

matias.vested@regionh.dk

+4535457547

Lars Lundstrøm, MD, Phd

Role: primary

lars.hyldborg.lundstroem.02@regionh.dk

+4548296512

Other Identifiers

2025-521405-40-01

Identifier Type: CTIS

Identifier Source: secondary_id

ROCVIDEO

Identifier Type: -

Identifier Source: org_study_id