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Stroke ThrombectomyMOONRISENCT05525325

Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

A study testing General Anesthesia in people with Stroke Thrombectomy, run by University Hospital Heidelberg at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke Thrombectomy
What is being tested?
General Anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteGermany
Study dates
1 Oct 2022to Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Min Chen, MD contact

0049/6221/7504

min.chen@med.uni-heidelberg.de

Germany1 site, 1 recruiting

  • Department of Neurology, University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Silvia Schönenberger, Dr., 0049-6221-5637549, silvia.schoenenberger@med.uni-heidelberg.de

    Silvia Schönenberger, Dr.

    Recruiting

Other trials in Germany

About this study

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

Read the 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.

Being tested
General Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General AnesthesiaProcedure or surgery

    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 groups in NCT05525325
Study groupRoleWhat they receive
General Anesthesia GroupActive comparatorPatients randomized to the GA arm are intubated after anesthetic induction.
Receives: Procedure: General Anesthesia
Procedural Sedation GroupExperimentalAfter randomization into the PS arm, the need for analgesics or sedatives are evaluated clinically.
Receives: Procedure: General Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    0-6; higher mean worse outcome

    Measured: 90 days +/- 2 weeks

Secondary outcomes (5)

  1. Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission

    0-42 points; higher mean worse outcome

    Measured: [NIHSS on admission - NIHSS after 24 hours]

  2. Mortality

    cerebral or non-cerebral cause of death

    Measured: intra-hospital until discharge up to 2 weeks [yes/no] and over the whole follow-up period up to 3 months [time to event]

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

    semi-quantitative method for grading irreversible ischemia in the vertebrobasilar system; 0-10 points; lower mean higher infarct volumes

    Measured: 12-36 hours after admission

  4. Feasibility of EST

    e.g. necessity of intubation, cardio-respiratory stability, loss in level of consciousness, loss of cough reflex, vomiting

    Measured: duration of thrombectomy procedure in minutes

  5. Complications before/during and after EST

    e.g. severe agitation, loss of level of consciousness, loss of cough reflex, vomiting, cardio-respiratory stability

    Measured: duration of the whole hospital stay in days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start1 Oct 2022
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525325
Sponsor's protocol ID
MOONRISE
Acronym
MOONRISE
Status last verified
Apr 2026
First submitted
23 Aug 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28395002

  • 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.

    PubMed 34603184

  • 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.

    PubMed 31573636

Questions about this trial

What is this clinical trial studying?

A study testing General Anesthesia in people with Stroke Thrombectomy, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Min Chen, MD (0049/6221/7504, min.chen@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcome as measured by modified Ranking Scale (mRS) after admission. (time frame: 90 days +/- 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525325, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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