Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke (MOONRISE)

• ClinicalTrials.gov Identifier: NCT05525325
• Recruitment Status: Recruiting
• First Posted: September 1, 2022
• Last Update Posted: October 12, 2022
• Sponsor: University Hospital Heidelberg
• Information provided by (Responsible Party): Dr. Silvia Schönenberger, MD, University Hospital Heidelberg

Tracking Information

• First Submitted Date: August 23, 2022
• First Posted Date: September 1, 2022
• Last Update Posted Date: October 12, 2022
• Actual Study Start Date: October 1, 2022
• Estimated Primary Completion Date: October 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stroke Thrombectomy

Intervention

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

• 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 *

• 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.
• 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.
• 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. Erratum In: JAMA. 2019 Dec 24;322(24):2445.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 30, 2022): 128
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2027
• Estimated Primary Completion Date: October 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Min Chen, MD; 0049/6221/7504; min.chen@med.uni-heidelberg.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT05525325
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Dr. Silvia Schönenberger, MD, University Hospital Heidelberg
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Heidelberg
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Silvia Schönenberger, MD; University Hospital Heidelberg
• Principal Investigator: Min Chen, MD; UUHeidelberg

• PRS Account: University Hospital Heidelberg
• Verification Date: October 2022