History of Changes for Study: NCT05525325

Sedation During Endovascular Treatment of Vetrebrobasilar Stroke (MOONRISE)

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Study Record Versions

Version	Submitted Date	Changes
1	August 30, 2022	None (earliest Version on record)
2	September 1, 2022	Study Status and Study Identification
3	October 6, 2022	Recruitment Status, Study Status and Contacts/Locations
4	October 11, 2022	Study Status
5	May 7, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	MOONRISE
Brief Title:	Sedation During Endovascular Treatment of Vetrebrobasilar Stroke (MOONRISE)
Official Title:	Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
Secondary IDs:

Study Status


Record Verification:	August 2022
Overall Status:	Not yet recruiting
Study Start:	October 1, 2022
Primary Completion:	October 2026 [Anticipated]
Study Completion:	January 2027 [Anticipated]

First Submitted:	August 23, 2022
First Submitted that Met QC Criteria:	August 30, 2022
First Posted:	September 1, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	August 30, 2022
Last Update Posted:	September 1, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	University Hospital Heidelberg
Responsible Party:	Principal Investigator Investigator: Dr. Silvia Schönenberger, MD Official Title: Head of Section of Neurointensive Care Affiliation: University Hospital Heidelberg
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

Conditions


Conditions:	Stroke Thrombectomy
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	128 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Active Comparator: General Anesthesia Group

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

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.

Experimental: Procedural Sedation Group

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

Procedure: General Anesthesia

Outcome Measures


Primary Outcome Measures:
1.	Functional outcome as measured by modified Ranking Scale (mRS) after admission. [ Time Frame: 90 days +/- 2 weeks ] 0-6; higher mean worse outcome
Secondary Outcome Measures:
1.	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
2.	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
3.	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
4.	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
5.	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

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: 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) Exclusion Criteria: 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)

Contacts/Locations


Central Contact Person:	Min Chen, MD Telephone: 0049/6221/7504 Email: min.chen@med.uni-heidelberg.de
Study Officials:	Silvia Schönenberger, MD Principal Investigator University Hospital Heidelberg
	Min Chen, MD Principal Investigator UUHeidelberg
Locations:	Germany, Baden-Württemberg
	Department of Neurology, University Hospital Heidelberg Heidelberg, Baden-Württemberg, Germany, 69120

IPDSharing


Plan to Share IPD:	No

References


Citations:	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
	[Study Results] 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. PubMed 31573636
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