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Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS)

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ClinicalTrials.gov Identifier: NCT03229148
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Direction Générale de l'Offre de Soins
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
Objective of the study: to assess whether pharmacological sedation or general anesthesia for treatment of anterior circulation ischemic stroke with endovascular mechanical thrombectomy is associated with difference in morbidity (neurological outcome and peri-procedural complications).

Condition or disease Intervention/treatment Phase
Stroke Thrombectomy Anesthesia Conscious Sedation Procedure: General anaesthesia Procedure: Conscious Sedation Not Applicable

Detailed Description:

Since 2015, the management of anterior acute ischemic stroke (AIS) involves endovascular treatment with mechanical thrombectomy (MT). This urgent, difficult and uncomfortable procedure in frail patients requires multidisciplinary care ideally involving neurologists, interventional neuroradiologists and anesthesiologists.

Two anesthetic strategies are currently used: pharmacologic sedation in spontaneous ventilation or general anesthesia with tracheal intubation. General anesthesia provides strict immobility, protects the airway and avoids emergency intubation in case of severe procedural complication (notably vomiting and aspiration). Sedation is a frequently used alternative because of (1) a rapid execution which could reduce delay to reperfusion, (2) a lower risk of blood pressure drop that may compromise cerebral blood flow in the penumbra area, (3) the theoretical capacity to assess neurological status during the procedure and (4) the supposed risk of complications associated with mechanical ventilation and intravenous anesthestics on brain metabolism. Nevertheless, sedation exposes to dramatic complications in case of patient agitation and movements.

The choice of the ideal anesthesic management is still lacking. Old retrospective studies seemed to favor sedation with worst neurological outcome associated with general anesthesia. Nevertheless, these datas suffered methodological issues with selection bias: more severe patients based on NIHSS score were rather treated with general anesthesia and blood pressure was not controlled. Recent studies that demonstrated the benefit of MT did not include a specific anesthetic protocol and none of the studies currently available included a blood pressure management protocol that appears to be an essential component of cerebral perfusion. A subgroup analysis of the MR Clean study, including patients with an identical initial NIHSS score, did not find benefit from MT in patients with general anesthesia compared to those receiving sedation. Finally, authors concluded that performing a MT under general anesthesia would significantly lengthen the reperfusion delay and nullify the benefit of MT.

The prospective, randomized, single-center SIESTA trial, conducted in 150 patients with an anterior circulation AIS, found no difference in the early neurological improvement (primary endpoint), assessed on the change in NIHSS score between admission and the 24th hour, between the conscious sedation group and the general anesthesia group. There were a tendency for a better 3-month neurological outcome in the general anesthesia group (37% vs 18% of patients with a Modified Rankin score of 0-2 in the general anesthesia and conscious sedation groups respectively), but it was not possible to conclude due to a lack of statistical power.

Due to the increasing number of patients eligible for endovascular MT and the potential implication of these two anesthetic management on the functional outcome, a study comparing general anesthesia and sedation during a MT seems essential as specified in the recent updated American Stroke Association guidelines.

The objective of this study is to assess whether sedation or general anesthesia during endovascular treatment with mechanical thrombectomy is associated with a difference in morbidity (neurological outcome and peri-procedural complications), in anterior circulation AIS.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentic, prospective, open, in parallel groups, stratified and randomised study.
Masking: Single (Outcomes Assessor)
Masking Description: It is an open label trial because it is not possible to maintain the anesthesiologist and patient blinded during the procedure. However, all subsequent evaluations will be conducted by clinical research staff blinded to the randomization group.
Primary Purpose: Treatment
Official Title: Anesthesia Management in Endovascular Therapy for Ischemic Stroke: A Multicenter Randomised Study
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Active Comparator: General anaesthesia
In the general anesthesia group, rapid sequence induction is used. Conduction of general anesthesia and drugs used are left to the expertise of each investigating center. Systolic blood pressure has to be maintained between 140 and 180 mmHg with an intravenous norepinephrine infusion if necessary, tele-expiratory carbon dioxyde concentration (EtCO2) has to be maintained between 30 and 35 mmHg and SpO2 has to be maintained between 94 and 98 %.
Procedure: General anaesthesia
Procedure in which patients are induced into an unconscious state through use of various medications so that they do not feel pain during surgery

Active Comparator: Conscious Sedation
In the conscious sedation group, drugs choice as well as pharmacological modulation will be left to the expertise of each investigating center. A sedation level between 0 and -3 with spontaneous breathing will be targeted, using the Richmond Agitation Sedation Scale (RASS) score validated in French. The lightest sedation level will be targeted, i.e. minimal to moderate sedation according to the US recommendations for sedation / analgesia. Systolic blood pressure will be maintained between 140 and 180 mmHg with an intravenous norepinephrine infusion if necessary and SpO2 will be maintained between 94 and 98%.
Procedure: Conscious Sedation
A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway. (From: American Society of Anesthesiologists Practice Guidelines)




Primary Outcome Measures :
  1. composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS [ Time Frame: on day 7 ]
    The primary outcome measure is a composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a mRS score 0 to 2 by day 90. Medical complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or acute cardiogenic pulmonary oedema or malignant stroke evolution occurring by day 7


Secondary Outcome Measures :
  1. Ordinal score on the mRS by day 90 [ Time Frame: at day 90 ]
  2. Functional independence by day 90 defined as a mRS score 0-2 [ Time Frame: at day 90 ]
  3. Excellent recovery by day 90 defined as a mRS score 0-1 [ Time Frame: at day 90 ]
  4. Moderate recovery by day 90 defined as a mRS score 0-3 [ Time Frame: at day 90 ]
  5. Shift analysis of day 90 mRS adjusted for initial prognostic factors [ Time Frame: at day 90 ]
    (baseline mRS, age, initial NIHSS, carotid top occlusion)

  6. Good recovery defined with sliding dichotomy responder analysis relating day 90 mRS with baseline NIHSS score: mRS 0 for NIHSS ≤ 7; mRS 0-1 for NIHSS 8-14; mRS 0-2 for NIHSS > 14 [ Time Frame: at day 90 ]
  7. Intraprocedural hemodynamic and ventilatory conditions and complications defined as hypotension, blood pressure variability, hypoxemia and aspiration [ Time Frame: at day 90 ]
  8. Intervention-associated vessel and others complications defined as arterial dissection or perforation, groin hematoma, embolization in another arterial territory [ Time Frame: at day 90 ]
  9. Door to groin puncture delay [ Time Frame: at day 90 ]
  10. Door to reperfusion delay [ Time Frame: at day 90 ]
  11. Successful reperfusion defined by the modified Treatment In Cerebral Ischemia (mTICI) reperfusion scale of 2b or 3 (with a grade of 2b or 3 indicating reperfusion of > 50% of the affected territory) [ Time Frame: at day 90 ]
  12. NIHSS by day 1 and day 7 [ Time Frame: by day 1 and day 7 ]
  13. Stroke unit and hospital length of stay [ Time Frame: at day 90 ]
  14. Medical complications by day 7 defined as pneumonia, acute cardiogenic pulmonary oedema, myocardial infarction, extra pulmonary infection, venous thromboembolism, new event of AIS, epilepsy, gastrointestinal bleeding or other symptomatic bleeding [ Time Frame: at day 7 ]
  15. Malignant stroke evolution by day 7 [ Time Frame: by day 7 ]
  16. Symptomatic intracranial haemorrhage by day 7 defined as brain haemorrhage on imaging associated with an increase of at least 4 points in the NIHSS score [ Time Frame: by day 7 ]
  17. Unexpected intensive care unit admission by day 7 [ Time Frame: by day 7 ]
  18. Mortality by day 7 and day 90 [ Time Frame: by day 7 and day 90 ]
  19. Procedural feasibility score estimated by the radiologist and the anaesthesiologist and patient acceptability score [ Time Frame: by day 7 and day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute anterior circulation ischemic stroke (terminal portion of the internal carotid artery, middle cerebral artery), with indication for radiological mechanical thrombectomy assessed by the neurology / neuroradiology team
  • Over 18 years of age
  • Benefiting from an affiliation to the French Social Security system
  • Patient or familly informed consent. In case of patient incapacity and no family present, and due to the emergency of the procedure, the patient may be included on the sole decision of the investigator (emergency procedure with subsequent differed consent).
  • Stroke complicating another acute illness or postoperative stroke.

Exclusion Criteria:

  • Altered vigilance defined by score ≥ 2 at item 1a "level of consciousness" of the NIHSS score
  • Altered previous autonomy, defined by a modified Rankin score (mRS)> 1
  • Acute ischemic stroke of posterior circulation or anterior cerebral artery
  • Associated brain haemorrhage
  • Pregnant or nursing women
  • Patient under law protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229148


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Charlotte FERNANDEZ-CANAL, MD         
Principal Investigator: Russel CHABANNE, MD         
Sub-Investigator: Anne-Claire LUKASZEWICZ, MD PhD         
Sub-Investigator: Serge MOLLIEX, MD PhD         
Sub-Investigator: Thomas GEERAERTS, MD PhD         
Sub-Investigator: Pierre-François PERRIGAULT, MD         
Sub-Investigator: Lionel VELLY, MD PhD         
Sub-Investigator: Benoit TAVERNIER, MD PhD         
Sub-Investigator: Marie GILLES-BARAY, MD         
Sub-Investigator: Vincent DEGOS, MD PhD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Direction Générale de l'Offre de Soins
Investigators
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Principal Investigator: Russel Chabanne, MD CHU de Clermont-Ferrand

Publications:
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03229148     History of Changes
Other Study ID Numbers: CHU-343
2017-0303001-90 ( Other Identifier: 2017-0303001-90 )
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Anesthesia or Conscious sedation for Thrombectomy for Stroke
Thrombectomy
Anesthesia
Conscious sedation
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs