Tracheal IntubationPhase 4ROCVIDEONCT06564857
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
A Phase 4 study testing Remifentanil and Rocuronium in people with Tracheal Intubation and Video Laryngoscopy, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation, Video Laryngoscopy, Remifentanil
- What is being tested?
- Remifentanil and Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,684 participants
- Where
- 2 sitesDenmark
- Study dates
- 17 Nov 2025to 8 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology, NOH, Rigshospitalet
Copenhagen, 2100
Matias Vedsted, MD, PhD, +4535457547, matias.vested@regionh.dk
- Recruiting
Department of Anesthesiology, North Zeeland Hospital
Hillerød, 3400
Lars Lundstrøm, MD, Phd, +4548296512, lars.hyldborg.lundstroem.02@regionh.dk
About this study
Official title: 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.
- Conditions
- Tracheal Intubation, Video Laryngoscopy, Remifentanil, Rocuronium
- Being tested
- Remifentanil, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Remifentanil 5 mg diluted in 100 ml saline, which corresponds to Remifentanil 50 micrograms/ml
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
RocuroniumDrug
Also called Rocuronium 10 mg/ml
Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| REMI-arm | Experimental | Bolus of remifentanil at anaesthesia induction Receives: Drug: Remifentanil |
| ROCU-arm | Active comparator | Bolus of rocuronium at anaesthesia induction Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
Secondary outcomes (3)
Patient satisfaction score
The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))
Measured: 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).
Measured: 0 minutes to 7 days after administration of drugs for intubation
Lengths of stay at the Post-Anaesthesia Care Unit.
Minutes the patient is at the Post-Anaesthesia Care Unit.
Measured: 0-48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start17 Nov 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion8 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, multicenter
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders K Nørskov, PhD, Principal investigator, Department of Anaesthesia, Nordsjællands Hospital - Hillerød, DenmarkMatias Vested, PhD, Principal investigator, Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564857
- Sponsor's protocol ID
- ROCVIDEO
- Other IDs
- 2025-521405-40-01, 2025
- Acronym
- ROCVIDEO
- Status last verified
- Oct 2025
- First submitted
- 25 Jun 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available upon reasonable request
Publications
Ipsen EO, Lundstrom LH, Lodenius A, Fisker G, Hovind MF, Nielsen CL, Oskarsdottir H, Strom C, Rosenstock CV, Madsen KPD, Wichmann S, Afshari A, Andersen JH, Nedergaard HK, Bill L, Cronhjort M, Mathiesen O, Jakobsen JC, Vested M, Norskov AK. Remifentanil Versus Rocuronium for Optimising Video Laryngoscopy Assisted Tracheal Intubation-The ROCVIDEO Trial Protocol. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70277. doi: 10.1111/aas.70277.
PubMed 42304626
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO Trial
- ClinicalTrials.gov ID
- NCT06564857
- Acronym / sponsor ID
- ROCVIDEO / ROCVIDEO
- Conditions
- Tracheal Intubation, Video Laryngoscopy, Remifentanil, Rocuronium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,684 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 8 Apr 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment, multicenter
| Arm | Type | Receives |
|---|---|---|
| REMI-arm | Experimental | Drug: RemifentanilBolus of remifentanil at anaesthesia induction |
| ROCU-arm | Active comparator | Drug: RocuroniumBolus of rocuronium at anaesthesia induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilAlso: Remifentanil 5 mg diluted in 100 ml saline, which corresponds to Remifentanil 50 micrograms/mlAge < 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 | Drug | REMI-arm |
| RocuroniumAlso: Rocuronium 10 mg/mlBolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction | Drug | ROCU-arm |
Primary outcome
Proportion of participants with one or more intubation or anaesthesia related adverse events
Time frame: 0 minutes to 24 hours after administration of drugs for intubation
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.
Proportion of participants with failed first-pass intubation
Time frame: Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
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.
3 secondary outcomes
Patient satisfaction score
Time frame: 24 hours after administration of drugs for intubation
Proportion of participants with one or more serious adverse events 0-7 days
Time frame: 0 minutes to 7 days after administration of drugs for intubation
Lengths of stay at the Post-Anaesthesia Care Unit.
Time frame: 0-48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42304626Ipsen EO, Lundstrom LH, Lodenius A, Fisker G, Hovind MF, Nielsen CL, Oskarsdottir H, Strom C, Rosenstock CV, Madsen KPD, Wichmann S, Afshari A, Andersen JH, Nedergaard HK, Bill L, Cronhjort M, Mathiesen O, Jakobsen JC, Vested M, Norskov AK. Remifentanil Versus Rocuronium for Optimising Video Laryngoscopy Assisted Tracheal Intubation-The ROCVIDEO Trial Protocol. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70277. doi: 10.1111/aas.70277.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders K Nørskov, PhD principal investigator
Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark
Matias Vested, PhD principal investigator
Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Rocuronium in people with Tracheal Intubation and Video Laryngoscopy, run by Nordsjaellands Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders K Nørskov, PhD (48292510 ext. +45, anders.kehlet.noerskov@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with one or more intubation or anaesthesia related adverse events (time frame: 0 minutes to 24 hours after administration of drugs for intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.