Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

Not Applicable

Recruiting

• Conditions: Stroke Thrombectomy
• Interventions: Procedure: General Anesthesia

• Registration Number: NCT05525325
• Lead Sponsor: University Hospital Heidelberg

Brief 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

Detailed Description

Endovascular treatment has become standard of care for many patients with acute ischemic strokes due to large vessel occlusions and is recommended by several national and international guidelines. Several studies have shown that anesthetic modality during endovascular treatment might affect the functional outcome. While much evidence has been generated for ischemic stroke of the anterior circulation, only a few studies have investigated anesthetic modalities in strokes with occlusions of the vertebrobasilar arteries. The majority of patients with vertebrobasilar occlusion strokes undergo endovascular procedure in general anesthesia and not a less burdensome sedation despite the lack of evidence for that approach. A few retrospective studies and a small single-center prospective randomized trial investigating this topic indicate that primary procedural sedation might be a feasible anesthetic approach. Here we aim to provide further high-level evidence by conducting a prospective randomized clinical trial with a PROBE (parallel-group, open-label randomized controlled with blinded endpoint evaluation) design for this research question.

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Study Start: 2022-10-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-10
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procedural Sedation Group	General Anesthesia	After randomization into the PS arm, the need for analgesics or sedatives are evaluated clinically.
General Anesthesia Group	General Anesthesia	Patients randomized to the GA arm are intubated after anesthetic induction.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission	[NIHSS on admission - NIHSS after 24 hours]	0-42 points; higher mean worse outcome
Mortality	intra-hospital until discharge up to 2 weeks [yes/no] and over the whole follow-up period up to 3 months [time to event]	cerebral or non-cerebral cause of death
Postinterventional pc-ASPECTS, determined with CT or MRI post-interventional follow up scan	12-36 hours after admission	semi-quantitative method for grading irreversible ischemia in the vertebrobasilar system; 0-10 points; lower mean higher infarct volumes
Complications before/during and after EST	duration of the whole hospital stay in days	e.g. severe agitation, loss of level of consciousness, loss of cough reflex, vomiting, cardio-respiratory stability
Feasibility of EST	duration of thrombectomy procedure in minutes	e.g. necessity of intubation, cardio-respiratory stability, loss in level of consciousness, loss of cough reflex, vomiting

Trial Locations

Locations (1)

Department of Neurology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany