Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

NCT06564857 | Recruiting Phase 4 DMC

• 2 other identifiers: ROCVIDEO2025-521405-40-01
• Study Type: interventional
• Target: 2,648
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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.

  0 minutes to 24 hours after administration of drugs for intubation

• 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.

  Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.

Secondary Outcomes (3)

• Patient satisfaction score

  24 hours after administration of drugs for intubation

• Proportion of participants with one or more serious adverse events 0-7 days

  0 minutes to 7 days after administration of drugs for intubation

• Lengths of stay at the Post-Anaesthesia Care Unit.

  0-48 hours postoperatively

Other Outcomes (7)

• Proportion of participants with failed intubation

  2 to 20 minutes after administration of drugs for intubation

• Number of intubation attempts

  2 to 20 minutes after administration of drugs for intubation

• Vocal cords position at first intubation attempt

  2 to 20 minutes after administration of drugs for intubation

Study Arms (2)

REMI-arm

EXPERIMENTAL

Bolus of remifentanil at anaesthesia induction

Drug: Remifentanil

ROCU-arm

ACTIVE COMPARATOR

Bolus of rocuronium at anaesthesia induction

Drug: Rocuronium

Interventions

Remifentanil 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

Also known as: Remifentanil 5 mg diluted in 100 ml saline, which corresponds to Remifentanil 50 micrograms/ml

REMI-arm

Rocuronium DRUG

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

Also known as: Rocuronium 10 mg/ml

ROCU-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (2)

Department of Anesthesiology, NOH, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Anesthesiology, North Zeeland Hospital

Hillerød, 3400, Denmark

RECRUITING

MeSH Terms

Interventions

Remifentanil; Sodium Chloride; Rocuronium

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anders K Nørskov, PhD

  Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark

  PRINCIPAL INVESTIGATOR

• Matias Vested, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders K Nørskov, PhD

CONTACT

48292510; anders.kehlet.noerskov@regionh.dk

Lars H Lundstrøm, PhD

CONTACT

48296512; lars.hyldborg.lundstroem.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, multicenter

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: August 21, 2024
• Study Start: November 17, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 8, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The protocol is submitted prior to first randomisation. A comprehensive statistical analysis plan, including pre-specified subgroup analysis will be published before the final participant is enrolled. Other material will be made available \<12 months after trial cessation
• Access Criteria: Anonymised data will be made available upon reasonable request.

Locations

DK (2)