Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-25 @ 4:31 PM
Study NCT ID:
NCT06564857
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment, multicenter'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2648}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-04-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of participants with failed intubation', 'timeFrame': '2 to 20 minutes after administration of drugs for intubation', 'description': 'The intubation is abandoned'}, {'measure': 'Number of intubation attempts', 'timeFrame': '2 to 20 minutes after administration of drugs for intubation', 'description': "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.\n\nAdditionally 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"}, {'measure': 'Vocal cords position at first intubation attempt', 'timeFrame': '2 to 20 minutes after administration of drugs for intubation', 'description': 'Categorised as closed, intermediate or open'}, {'measure': 'Proportion of participants with need for rescue medication or airway management', 'timeFrame': '2 to 20 minutes after administration of drugs for intubation', 'description': '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.'}, {'measure': 'Proportion of participants with anaesthesia induction related grave desaturation', 'timeFrame': '0 to 10 minutes after administration of drugs for intubation', 'description': 'SAT \\< 80%'}, {'measure': 'Proportion of participants in need of vasoactive or chronotropic substances after induction', 'timeFrame': '0 to 10 minutes after administration of drugs for intubation', 'description': 'Defined as any vasoactive substance, e.g. epinephrine, noradrenaline, phenylephrine, ephedrine administrated as a response to severe hypotension or bradycardia after induction.'}, {'measure': '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"', 'timeFrame': '0 minutes to 7 days after administration of drugs for intubation', 'description': 'As stated in the relevant outcome descriptions'}], 'primaryOutcomes': [{'measure': 'Proportion of participants with one or more intubation or anaesthesia related adverse events', 'timeFrame': '0 minutes to 24 hours after administration of drugs for intubation', 'description': '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).\n\nLate (\\< 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.'}, {'measure': 'Proportion of participants with failed first-pass intubation', 'timeFrame': 'Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.', 'description': "Defined as failed tracheal tube delivery after the first attempt of introduction of the video laryngoscope into the patient's mouth.\n\nTracheal 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."}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction score', 'timeFrame': '24 hours after administration of drugs for intubation', 'description': "The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))"}, {'measure': 'Proportion of participants with one or more serious adverse events 0-7 days', 'timeFrame': '0 minutes to 7 days after administration of drugs for intubation', 'description': '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).'}, {'measure': 'Lengths of stay at the Post-Anaesthesia Care Unit.', 'timeFrame': '0-48 hours postoperatively', 'description': 'Minutes the patient is at the Post-Anaesthesia Care Unit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tracheal Intubation', 'Video Laryngoscopy', 'Remifentanil', 'Rocuronium']}, 'descriptionModule': {'briefSummary': "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.\n\nEvidence 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Undergoing general anaesthesia requiring oro-tracheal intubation\n* Absence of indication for rapid sequence induction\n* American Society of Anesthesiologists (ASA) physical status score I - III\n\nExclusion Criteria:\n\n* Known allergies or contraindications to rocuronium (e.g. neuromuscular disease) or remifentanil\n* Awake intubation\n* Double-lumen endotracheal tube\n* Oral, pharyngeal, and laryngeal surgery\n* Surgical contraindication for NMBAs (e.g. use of nerve stimulator)\n* Patients who are pregnant or breastfeeding\n* Patients who do not understand Danish or are unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT06564857', 'acronym': 'ROCVIDEO', 'briefTitle': 'Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO Trial', 'orgStudyIdInfo': {'id': 'ROCVIDEO'}, 'secondaryIdInfos': [{'id': '2025-521405-40-01', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REMI-arm', 'description': 'Bolus of remifentanil at anaesthesia induction', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ROCU-arm', 'description': 'Bolus of rocuronium at anaesthesia induction', 'interventionNames': ['Drug: Rocuronium']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Remifentanil 5 mg diluted in 100 ml saline, which corresponds to Remifentanil 50 micrograms/ml'], 'description': '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', 'armGroupLabels': ['REMI-arm']}, {'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Rocuronium 10 mg/ml'], 'description': 'Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction', 'armGroupLabels': ['ROCU-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Matias Vedsted, MD, PhD', 'role': 'CONTACT', 'email': 'matias.vested@regionh.dk', 'phone': '+4535457547'}], 'facility': 'Department of Anesthesiology, NOH, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '3400', 'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lars Lundstrøm, MD, Phd', 'role': 'CONTACT', 'email': 'lars.hyldborg.lundstroem.02@regionh.dk', 'phone': '+4548296512'}], 'facility': 'Department of Anesthesiology, North Zeeland Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'centralContacts': [{'name': 'Anders K Nørskov, PhD', 'role': 'CONTACT', 'email': 'anders.kehlet.noerskov@regionh.dk', 'phone': '48292510', 'phoneExt': '+45'}, {'name': 'Lars H Lundstrøm, PhD', 'role': 'CONTACT', 'email': 'lars.hyldborg.lundstroem.02@regionh.dk', 'phone': '48296512', 'phoneExt': '+45'}], 'overallOfficials': [{'name': 'Anders K Nørskov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark'}, {'name': 'Matias Vested, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '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.\n\nOther material will be made available \\<12 months after trial cessation', 'ipdSharing': 'YES', 'description': 'Anonymised data will be made available upon reasonable request', 'accessCriteria': 'Anonymised data will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}