Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

NCT ID: NCT05525325

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2027-01-31

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

Stroke Thrombectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

General Anesthesia Group

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

Group Type: ACTIVE_COMPARATOR

General Anesthesia

Intervention Type: 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.

Procedural Sedation Group

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

Group Type: EXPERIMENTAL

General Anesthesia

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. Silvia Schönenberger, MD

Head of Section of Neurointensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Schönenberger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Min Chen, MD

Role: PRINCIPAL_INVESTIGATOR

UUHeidelberg

Locations

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Min Chen, MD

Role: CONTACT

min.chen@med.uni-heidelberg.de

0049/6221/7504

Facility Contacts

Silvia Schönenberger, Dr.

Role: primary

silvia.schoenenberger@med.uni-heidelberg.de

0049-6221-5637549

References

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.

Reference Type: BACKGROUND

PMID: 28395002 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34603184 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31573636 (View on PubMed)

Other Identifiers

MOONRISE

Identifier Type: -

Identifier Source: org_study_id