Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

NCT05525325 | Recruiting DMC

• 1 other identifier: MOONRISE
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Functional outcome as measured by modified Ranking Scale (mRS) after admission.

  0-6; higher mean worse outcome

  90 days +/- 2 weeks

Secondary Outcomes (5)

• 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]

• 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]

• Postinterventional pc-ASPECTS, determined with CT or MRI post-interventional follow up scan

  12-36 hours after admission

• Feasibility of EST

  duration of thrombectomy procedure in minutes

• Complications before/during and after EST

  duration of the whole hospital stay in days

Study Arms (2)

General Anesthesia Group

ACTIVE COMPARATOR

Patients randomized to the GA arm are intubated after anesthetic induction.

Procedure: General Anesthesia

Procedural Sedation Group

EXPERIMENTAL

After randomization into the PS arm, the need for analgesics or sedatives are evaluated clinically.

Procedure: General Anesthesia

Interventions

General Anesthesia PROCEDURE

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.

General Anesthesia Group; Procedural Sedation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
• Age 18 years or older, either sex
• National Institutes of Health Stroke Scale (NIHSS) ≥ 4
• Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA)
• Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure)

You may not qualify if:

• Intracerebral hemorrhage
• Coma on admission (Glasgow Coma Scale ≤ 8)
• Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
• Intubated state before randomization
• Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (3)

• Jadhav AP, Bouslama M, Aghaebrahim A, Rebello LC, Starr MT, Haussen DC, Ranginani M, Whalin MK, Jovin TG, Nogueira RG. Monitored Anesthesia Care vs Intubation for Vertebrobasilar Stroke Endovascular Therapy. JAMA Neurol. 2017 Jun 1;74(6):704-709. doi: 10.1001/jamaneurol.2017.0192.

  PMID: 28395002 BACKGROUND

• Weyland CS, Chen M, Potreck A, Jager LB, Seker F, Schonenberger S, Bendszus M, Mohlenbruch M. Sedation Mode During Endovascular Stroke Treatment in the Posterior Circulation-Is Conscious Sedation for Eligible Patients Feasible? Front Neurol. 2021 Sep 17;12:711558. doi: 10.3389/fneur.2021.711558. eCollection 2021.

  PMID: 34603184 BACKGROUND

• Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455.

  PMID: 31573636 RESULT

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Silvia Schönenberger, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Min Chen, MD

  UUHeidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Chen, MD

CONTACT

0049/6221/7504; min.chen@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Section of Neurointensive Care

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 1, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)