Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2

NCT07235514 | Not Yet Recruiting DMC

• 2 other identifiers: PHRC 2024 CHABANNE2025-A00169-40
• Study Type: interventional
• Target: 958
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel. The main question it aims to answer is: • Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke? GA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased. Researchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke. Participants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.

Conditions

Ischemic Stroke; Anterior Cerebral Circulation; General Anesthesia; Procedural Sedation; Thrombectomy

Keywords

Ischemic stroke; anterior circulation; mechanical thrombectomy; anesthetic strategy; general anesthesia; procedural sedation; functional outcome; large vessel occlusion stroke

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale

  modified Rankin Scale, that range from 0 to 6: 0, no neurologic deficit; 1, no clinically significant disability; 2, slight disability; 3, moderate disability requiring some help; 4, moderately severe disability; 5, severe disability; 6, death \> measured centrally by a blinded evaluator

  Day 90 after the stroke

Secondary Outcomes (21)

• Functional independence = key secondary outcome

  Day 90 after the stroke

• Modified Treatment in Cerebral Infarction scale at the end of thrombectomy (mTICI).

  At day 1 (end of the thrombectomy procedure)

• Good quality of reperfusion defined as a mTICI score of 2b-3

  At day 1 (end of the thrombectomy procedure)

• Excellent quality of reperfusion defined as a mTICI score of 2c-3

  At day 1 (end of the thrombectomy procedure)

• National Institute of Health Stroke Scale (NIHSS)

  At day 1 after the thrombectomy procedure

Study Arms (2)

General anesthesia

EXPERIMENTAL

General anesthesia with intubation and mechanical ventilation: ECG, SpO2 and BP. BP will be measured every 2 minutes Hyperglycemia (\>180mg/dL) and hypoglycemia (\<60mg/dL) should be treated (outside of the protocol) Systolic BP: 150 - 180mmHg with Diastolic BP \< 105mmHg Norepinephrine tartrate infusion or Nicardipine on a peripheral intravenous line or on a 3-way venous extender, as necessary EtCO2 35 - 45mmHg SpO2 above 94 %. Glycemia as needed End of procedure: Anesthesia will be immediately stopped and extubation should not be delayed. After the intervention, patients are transferred to the post anesthesia care unit and are then admitted to the stroke unit First 24 hours: SBP\<180mmHg, DBP\<110mmHg and MAP\>65mmHg, SpO2 \> 94 %, temperature \< 38°C, blood glucose 60 - 180mg/dL. Other aspects of monitoring are not modified by the protocol. 24-48h outside of the protocol: non-contrast brain CT or a brain MRI

Procedure: General Anesthesia

Procedural sedation

EXPERIMENTAL

Procedural sedation with spontaneous ventilation: ECG, SpO2 and BP. BP will be measured every 2 minutes Hyperglycemia (\>180mg/dL) and hypoglycemia (\<60mg/dL) should be treated (outside of the protocol) Systolic BP: 150 - 180mmHg with Diastolic BP \< 105mmHg Norepinephrine tartrate infusion or Nicardipine on a peripheral intravenous line or on a 3-way venous extender, as necessary Breathing face mask: EtCO2 and oxygen as necessary SpO2 above 94 %. Glycemia as needed End of procedure: Procedural sedation will be immediately stopped. After the intervention, patients are transferred to the post anesthesia care unit and are then admitted to the stroke unit First 24 hours: SBP\<180mmHg, DBP\<110mmHg and MAP\>65mmHg, SpO2 \> 94 %, temperature \< 38°C, blood glucose 60 - 180mg/dL. Other aspects of monitoring are not modified by the protocol. 24-48h outside of the protocol: non-contrast brain CT or a brain MRI

Procedure: Procedural sedation

Interventions

General Anesthesia PROCEDURE

In the general anesthesia (GA) group with tracheal intubation : Clinical target: unarousable state Standard preoxygenation, • Rapid sequence induction of GA will use intravenous Etomidate (0.2-0.3mg/Kg) or Ketamine (1-2mg/Kg) and Succinylcholine (1mg/Kg) or Rocuronium (1.2 mg/Kg) • Maintenance of GA will use intravenous Propofol (brain tissue target controlled infusion up to 4.0 µg/mL or up to 5.0 mg/kg/hr) or Sevoflurane (end-tidal concentration up to 2% (EtSevo)) and intravenous Remifentanil (brain tissue target controlled infusion up to 4.0 ng/mL) Movement despite unarousable state: NMBA as needed

Also known as: GA

General anesthesia

Procedural sedation PROCEDURE

In the procedural sedation group with spontaneous ventilation : Clinical target: alert and "confortable" i.e. minimal to moderate sedation level * Subcutaneous local anesthesia with Lidocaine 10mg/mL (maximum 10mL) * Intravenous Remifentanil as necessary to achieve the sedation clinical target (brain tissue target controlled infusion up to 2.0 ng/mL). Propofol could be added as necessary (brain tissue target controlled infusion up to 3.0 µg/mL or 2.0 mg/kg/hr). The lightest sedation level allowing the intervention has to be sought.

Also known as: PS

Procedural sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Acute ischemic stroke with an occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery (M1-M2) with or without association of extracranial occlusion of the cervical internal carotid artery (tandem lesion)
• Eligible for mechanical thrombectomy according to international guidelines
• Informed and signed consent of patient, or if he is unable to consent the consent of patient's relative or emergency procedure in the absence of relative
• National health insurance

You may not qualify if:

• Coma or altered vigilance defined as a score ≥ 2 on the level of consciousness 1A subscale of the NIHSS
• Premorbid disability defined as a mRS \> 2
• Posterior circulation stroke
• Associated cerebral hemorrhage
• Stroke complicating another acute illness or postoperative stroke
• Emesis at arrival in angiosuite
• Allergy to anesthetic medication
• Pregnant or breast-feeding women
• Adult under the protection of the law

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• PHRC, Ministry of Health France: collaborator
• STROKELINK: collaborator
• ANARLF Network: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Related Publications (6)

• 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.

  PMID: 31573636 BACKGROUND

• Chabanne R, Geeraerts T, Begard M, Balanca B, Rapido F, Degos V, Tavernier B, Molliex S, Velly L, Verdonk F, Lukaszewicz AC, Perrigault PF, Albucher JF, Cognard C, Guyot A, Fernandez C, Masgrau A, Moreno R, Ferrier A, Jaber S, Bazin JE, Pereira B, Futier E; ANARLF NetworkAMETIS Study Group. Outcomes After Endovascular Therapy With Procedural Sedation vs General Anesthesia in Patients With Acute Ischemic Stroke: The AMETIS Randomized Clinical Trial. JAMA Neurol. 2023 May 1;80(5):474-483. doi: 10.1001/jamaneurol.2023.0413.

  PMID: 37010829 BACKGROUND

• Maurice A, Eugene F, Ronziere T, Devys JM, Taylor G, Subileau A, Huet O, Gherbi H, Laffon M, Esvan M, Laviolle B, Beloeil H; GASS (General Anesthesia versus Sedation for Acute Stroke Treatment) Study Group and the French Society of Anesthesiologists (SFAR) Research Network. General Anesthesia versus Sedation, Both with Hemodynamic Control, during Intraarterial Treatment for Stroke: The GASS Randomized Trial. Anesthesiology. 2022 Apr 1;136(4):567-576. doi: 10.1097/ALN.0000000000004142.

  PMID: 35226737 BACKGROUND

• Quintard H, Degos V, Mazighi M, Berge J, Boussemart P, Chabanne R, Figueiredo S, Geeraerts T, Launey Y, Meuret L, Olivot JM, Pottecher J, Rapido F, Richard S, Saleme S, Siguret-Depasse V, Naggara O, De Courson H, Garnier M. Anaesthetic and peri-operative management for thrombectomy procedures in stroke patients. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101188. doi: 10.1016/j.accpm.2022.101188. Epub 2023 Jan 1.

  PMID: 36599377 BACKGROUND

• Turc G, Bhogal P, Fischer U, Khatri P, Lobotesis K, Mazighi M, Schellinger PD, Toni D, de Vries J, White P, Fiehler J. European Stroke Organisation (ESO) - European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic StrokeEndorsed by Stroke Alliance for Europe (SAFE). Eur Stroke J. 2019 Mar;4(1):6-12. doi: 10.1177/2396987319832140. Epub 2019 Feb 26.

  PMID: 31165090 BACKGROUND

• Powers WJ, Rabinstein AA. Response by Powers and Rabinstein to Letter Regarding Article, "2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association". Stroke. 2019 Sep;50(9):e277-e278. doi: 10.1161/STROKEAHA.119.026917. Epub 2019 Aug 8. No abstract available.

  PMID: 31390963 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Russell CHABANNE

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Open Blinded Endpoint trial (PROBE design)

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)