SYFbafdc3ad185540e0887028b2ba91586cRegistry ID: 2024-510752-12-00|RecruitingPhase 4
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interventional
N/A
1 country
1
The primary objective of the study is to assess the time from hospital arrival to revascularization in patients with acute ischemic stroke treated with mechanical thrombectomy, depending on whether the procedure was performed under sedation with HFNC or under general anesthesia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2024
Actual (reported)Time between arrival at the hospital door and arterial recanalization (in minutes). This time has been shown to be sensitive to the type of anesthetic procedure used in the different meta-analyses published and, in addition to including the time of the intervention, which may also be influenced by the anesthetic technique, it is less affected by other factors than other times collected for the assessment of stroke treatment, such as the time from onset of the clinic to recanalization.
NIHSS scale at 24 hours and the modified Rankin scale (mRS) 90 days after stroke.
Door time - arterial puncture: minutes. Arterial puncture time - recanalization: minutes
Degree of arterial recanalization, according to the mTICI scale (modified Thrombolysis in Cerebral Infarction Scale): 0-3
Incidence of complications during the intervention in both groups (arterial perforation, dissection, embolisms to new territories, complications at the point of arterial puncture, arterial hypertension or hypotension, arrhythmias, hypoxemia, and bronchial aspiration) as well as after the procedure (cerebral hemorrhage, hypertension or hypotension, arrhythmias, hypoxemia or pneumonia). Their presence will be assessed after 24 hours, and upon discharge from hospital.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Lidocaína B. Braun 10 mg/ml solución inyectable
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Fentanest 0,05 mg/ml solución inyectable
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Propofol Fresenius 10 mg/ml emulsión para inyección o perfusión
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EMULSION FOR INJECTION/INFUSION
View registry recordFormulated product
Esmeron 10 mg/ml solución inyectable y para perfusión
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Lidocaína B. Braun 10 mg/ml solución inyectable
Named ingredient: Lidocaine hydrochloride
View registry recordFentanest 0,05 mg/ml solución inyectable
Named ingredient: Fentanyl citrate
View registry recordPropofol Fresenius 10 mg/ml emulsión para inyección o perfusión
Named ingredient: Propofol
View registry recordEsmeron 10 mg/ml solución inyectable y para perfusión
Named ingredient: Rocuronium bromide
View registry recordHospital Universitario La Paz
Madrid, 28046, Spain
Pedro Navia Álvarez
First Submitted
June 26, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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