Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation (ROCVIDEO)

Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO 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.

Study Overview

• Status: Recruiting
• Conditions: Remifentanil; Tracheal Intubation; Rocuronium; Video Laryngoscopy
• Intervention / Treatment: Drug: Remifentanil; Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Estimated): 2648
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anders K Nørskov, PhD; Phone Number: +45 48292510; Email: anders.kehlet.noerskov@regionh.dk
• Study Contact Backup: Name: Lars H Lundstrøm, PhD; Phone Number: +45 48296512; Email: lars.hyldborg.lundstroem.02@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Anesthesiology, NOH, Rigshospitalet
    • Contact: Matias Vedsted, MD, PhD; Phone Number: +4535457547; Email: matias.vested@regionh.dk
  • Hillerød, Denmark, 3400
    • Recruiting
    • Department of Anesthesiology, North Zeeland Hospital
    • Contact: Lars Lundstrøm, MD, Phd; Phone Number: +4548296512; Email: lars.hyldborg.lundstroem.02@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REMI-arm; Bolus of remifentanil at anaesthesia induction	Drug: 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; Other Names: Remifentanil 5 mg diluted in 100 ml saline, which corresponds to Remifentanil 50 micrograms/ml
Active Comparator: ROCU-arm; Bolus of rocuronium at anaesthesia induction	Drug: Rocuronium; Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction; Other Names: Rocuronium 10 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lengths of stay at the Post-Anaesthesia Care Unit.	Minutes the patient is at the Post-Anaesthesia Care Unit.	0-48 hours postoperatively
Patient satisfaction score	The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))	24 hours after administration of drugs for intubation
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).	0 minutes to 7 days after administration of drugs for intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with failed intubation	The intubation is abandoned	2 to 20 minutes after administration of drugs for intubation
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	2 to 20 minutes after administration of drugs for intubation
Vocal cords position at first intubation attempt	Categorised as closed, intermediate or open	2 to 20 minutes after administration of drugs for intubation
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.	2 to 20 minutes after administration of drugs for intubation
Individual components of the composite outcomes "Proportion of participants with one or more intubation or anaesthesia related adverse events" and "Proportion of participants with one or more serious adverse events 0-7 days"	As stated in the relevant outcome descriptions	0 minutes to 7 days after administration of drugs for intubation
Proportion of participants with anaesthesia induction related grave desaturation	SAT < 80%	0 to 10 minutes after administration of drugs for intubation
Proportion of participants in need of vasoactive or chronotropic substances after induction	Defined as any vasoactive substance, e.g. epinephrine, noradrenaline, phenylephrine, ephedrine administrated as a response to severe hypotension or bradycardia after induction.	0 to 10 minutes after administration of drugs for intubation

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 8, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Polycyclic Compounds; Piperidines; Inorganic Chemicals; Chlorine Compounds; Steroids; Fused-Ring Compounds; Androstanes; Propionates; Sodium Compounds; Chlorides; Hydrochloric Acid; Androstanols; Remifentanil; Rocuronium; Sodium Chloride
• Other Study ID Numbers: ROCVIDEO; 2025-521405-40-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be made available upon reasonable request

IPD Sharing 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

• IPD Sharing Access Criteria: Anonymised data will be made available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No