- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06564857
Remifentanil versus Rocuronium pro optimalizaci tracheální intubace za pomoci videolaryngoskopie (ROCVIDEO)
Remifentanil versus Rocuronium pro optimalizaci videolaryngoskopie asistované tracheální intubace u pacientů podstupujících celkovou anestezii – multicentrická randomizovaná kontrolovaná studie – studie ROCVIDEO
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Anders K Nørskov, PhD
- Telefonní číslo: +45 48292510
- E-mail: anders.kehlet.noerskov@regionh.dk
Studijní záloha kontaktů
- Jméno: Lars H Lundstrøm, PhD
- Telefonní číslo: +45 48296512
- E-mail: lars.hyldborg.lundstroem.02@regionh.dk
Studijní místa
-
-
-
Copenhagen, Dánsko, 2100
- Nábor
- Department of Anesthesiology, NOH, Rigshospitalet
-
Kontakt:
- Matias Vedsted, MD, PhD
- Telefonní číslo: +4535457547
- E-mail: matias.vested@regionh.dk
-
Hillerød, Dánsko, 3400
- Nábor
- Department of Anesthesiology, North Zeeland Hospital
-
Kontakt:
- Lars Lundstrøm, MD, Phd
- Telefonní číslo: +4548296512
- E-mail: lars.hyldborg.lundstroem.02@regionh.dk
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: REMI-arm
Bolus of remifentanil at anaesthesia induction |
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
Ostatní jména:
|
|
Aktivní komparátor: ROCU-arm
Bolus of rocuronium at anaesthesia induction |
Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of participants with one or more intubation or anaesthesia related adverse events
Časové okno: 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. |
0 minutes to 24 hours after administration of drugs for intubation
|
|
Proportion of participants with failed first-pass intubation
Časové okno: 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. |
Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient satisfaction score
Časové okno: 24 hours after administration of drugs for intubation
|
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
Časové okno: 0 minutes to 7 days after administration of drugs for intubation
|
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
|
|
Lengths of stay at the Post-Anaesthesia Care Unit.
Časové okno: 0-48 hours postoperatively
|
Minutes the patient is at the Post-Anaesthesia Care Unit. |
0-48 hours postoperatively
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of participants with failed intubation
Časové okno: 2 to 20 minutes after administration of drugs for intubation
|
The intubation is abandoned |
2 to 20 minutes after administration of drugs for intubation
|
|
Number of intubation attempts
Časové okno: 2 to 20 minutes after administration of drugs for intubation
|
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
Časové okno: 2 to 20 minutes after administration of drugs for intubation
|
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
Časové okno: 2 to 20 minutes after administration of drugs for intubation
|
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
|
|
Proportion of participants with anaesthesia induction related grave desaturation
Časové okno: 0 to 10 minutes after administration of drugs for intubation
|
SAT < 80% |
0 to 10 minutes after administration of drugs for intubation
|
|
Proportion of participants in need of vasoactive or chronotropic substances after induction
Časové okno: 0 to 10 minutes after administration of drugs for intubation
|
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
|
|
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"
Časové okno: 0 minutes to 7 days after administration of drugs for intubation
|
As stated in the relevant outcome descriptions |
0 minutes to 7 days after administration of drugs for intubation
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Anders K Nørskov, PhD, Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark
- Vrchní vyšetřovatel: Matias Vested, PhD, Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Kyseliny, acyklické
- Karboxylové kyseliny
- Polycyklické sloučeniny
- Piperidiny
- Anorganické chemikálie
- Sloučeniny chloru
- Steroidy
- Sloučeniny roztaveného kruhu
- Androstanes
- Propionáty
- Sloučeniny sodíku
- Chloridy
- Kyselina chlorovodíková
- Androstanols
- Remifentanil
- Rokuronium
- Chlorid sodný
Další identifikační čísla studie
- ROCVIDEO
- 2025-521405-40-01 (Ctis)
- 2025 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Anonymised data will be made available upon reasonable request
Časový rámec sdílení IPD
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
Kritéria přístupu pro sdílení IPD
Anonymised data will be made available upon reasonable request.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .