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Trial record 1 of 1 for:    MOONRISE stroke
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Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke (MOONRISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05525325
Recruitment Status : Recruiting
First Posted : September 1, 2022
Last Update Posted : October 12, 2022
Information provided by (Responsible Party):
Dr. Silvia Schönenberger, MD, University Hospital Heidelberg

Tracking Information
First Submitted Date  ICMJE August 23, 2022
First Posted Date  ICMJE September 1, 2022
Last Update Posted Date October 12, 2022
Actual Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2022)
Functional outcome as measured by modified Ranking Scale (mRS) after admission. [ Time Frame: 90 days +/- 2 weeks ]
0-6; higher mean worse outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2022)
  • Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission [ Time Frame: [NIHSS on admission - NIHSS after 24 hours] ]
    0-42 points; higher mean worse outcome
  • Mortality [ Time Frame: 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 [ Time Frame: 12-36 hours after admission ]
    semi-quantitative method for grading irreversible ischemia in the vertebrobasilar system; 0-10 points; lower mean higher infarct volumes
  • Feasibility of EST [ Time Frame: duration of thrombectomy procedure in minutes ]
    e.g. necessity of intubation, cardio-respiratory stability, loss in level of consciousness, loss of cough reflex, vomiting
  • Complications before/during and after EST [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
Official Title  ICMJE Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke Thrombectomy
Intervention  ICMJE Procedure: 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 Arms  ICMJE
  • Active Comparator: General Anesthesia Group
    Patients randomized to the GA arm are intubated after anesthetic induction.
    Intervention: Procedure: General Anesthesia
  • Experimental: Procedural Sedation Group
    After randomization into the PS arm, the need for analgesics or sedatives are evaluated clinically.
    Intervention: Procedure: General Anesthesia
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2022)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2027
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Min Chen, MD 0049/6221/7504
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05525325
Other Study ID Numbers  ICMJE MOONRISE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr. Silvia Schönenberger, MD, University Hospital Heidelberg
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital Heidelberg
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvia Schönenberger, MD University Hospital Heidelberg
Principal Investigator: Min Chen, MD UUHeidelberg
PRS Account University Hospital Heidelberg
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP