Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

NCT05525325 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Heidelberg

Phase

Not applicable

Started

2022-10-01

Last updated

2026-04-30

Condition(s) studied

Stroke Thrombectomy

Investigational drug(s) / intervention(s)

General Anesthesia

General Anesthesia: Patients randomized to the GA arm are intubated after anesthetic induction. For this purpose, they are pre-oxygenated with an oxygen mask and non-invasive monitoring is established. After sufficient pre-oxygenation has been applied, analgesic and sedative medication are administered. If the patient is sufficiently long nil by mouth they are manually ventilated before a muscle relaxant is administered. A rapid-sequence induction is performed with administration of an opioid, sedative and muscle relaxant in rapid succession and without intermediate manual ventilation in non-nil by mouth patients. To secure the airway, an endotracheal tube is inserted into the trachea with the aid of a laryngoscope. After insertion of the endotracheal tube, its endotracheal position is confirmed with auscultation and capnography. GA maintenance therapy with opioids, sedatives and catecholamines, if needed, will then be started.

Study summary

Optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. We want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment 2. Age 18 years or older, either sex 3. National Institutes of Health Stroke Scale (NIHSS) ≥ 4 4. Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA) 5. Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure) Exclusion Criteria: 1. Intracerebral hemorrhage 2. Coma on admission (Glasgow Coma Scale ≤ 8) 3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary 4. Intubated state before randomization 5. Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)

Primary outcome measure(s)

Functional outcome as measured by modified Ranking Scale (mRS) after admission. — 90 days +/- 2 weeks
0-6; higher mean worse outcome

Trial sites (1)

Facility	City	Region	Status
Department of Neurology, University Hospital Heidelberg	Heidelberg	Baden-Wurttemberg	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05525325 on ClinicalTrials.gov ↗ ← All trials in Germany