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General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

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ClinicalTrials.gov Identifier: NCT02639806
Recruitment Status : Enrolling by invitation
First Posted : December 24, 2015
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Michael Kelly, University of Saskatchewan

Tracking Information
First Submitted Date December 18, 2015
First Posted Date December 24, 2015
Last Update Posted Date May 7, 2019
Study Start Date January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2015)
Shift in the mRS score, defined by a proportional odds model. [ Time Frame: 90 Days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2016)
  • The proportion of patients who achieve a NIHSS score 0-2 [ Time Frame: 90 Days ]
    Stroke severity. Clinical scale outcome score from 0 to 42.
  • The proportion of patients who achieve a mRS 0-2 [ Time Frame: 90 days ]
    Functional outcome. Dichotomous outcome, reported as independent (mRS 0-2) vs dependence or death (mRS 3-6). In addition, shift analysis (proportional odds model) representing the odds of improvement within the scale with treatment.
  • Recanalization of the target arterial occlusive lesion [ Time Frame: Day 0 ]
    Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.
  • Time from diagnostic CT to procedure initiation [ Time Frame: Day 0 ]
  • Time from the start of the procedure to vascular recanalization [ Time Frame: Day 0 ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 90 Days ]
    Episodes of hypo/hypertensive and bradycardic episodes that required the use of pharmacologic agent.; Symptomatic intracranial hemorrhage; Major bleeding; Contrast nephropathy; Malignant MCA infarction; Hemicraniectomy; Aspiration Pneumonia; Adverse airway event; other
Original Secondary Outcome Measures
 (submitted: December 22, 2015)
  • The proportion of patients who achieve a NIHSS score 0-2 [ Time Frame: 90 Days ]
    Stroke severity. Clinical scale outcome score from 0 to 42.
  • Reduced infarct volume as measured by post-procedure imaging [ Time Frame: 24-48 hrs ]
  • The proportion of patients who achieve a mRS 0-2 [ Time Frame: 90 days ]
    Functional outcome. Dichotomous outcome, reported as independent (mRS 0-2) vs dependence or death (mRS 3-6). In addition, shift analysis (proportional odds model) representing the odds of improvement within the scale with treatment.
  • Recanalization of the target arterial occlusive lesion [ Time Frame: Day 0 ]
    Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.
  • Time from diagnostic CT to procedure initiation [ Time Frame: Day 0 ]
  • Time from the start of the procedure to vascular recanalization [ Time Frame: Day 0 ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 90 Days ]
    Episodes of hypo/hypertensive and bradycardic episodes that required the use of pharmacologic agent.; Symptomatic intracranial hemorrhage; Major bleeding; Contrast nephropathy; Malignant MCA infarction; Hemicraniectomy; Aspiration Pneumonia; Adverse airway event; other
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
Official Title General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
Brief Summary This study evaluates the outcomes of stroke patients treated for intravascular thrombectomy, using either a local anesthetic with sedation, or a general anesthetic. Historical data will be used for those treated with the local anesthetic, and prospective data will be used for those treated with the general anesthetic.
Detailed Description

This is an open-label pilot study, comparing intravascular thrombectomy patients treated using either general anesthetic (prospective arm) or local anesthetic with sedation (retrospective arm), with blinded outcome evaluation.

New evidence has established that the addition of endovascular thrombectomy for large, and/or proximal occlusions improves outcome in addition to, and/or in place of tPA therapy. There have been no randomized prospective trials assessing the relationship of anesthesia on outcomes for this procedure. This procedure is routinely performed under either local anesthetic with sedation and under general anesthesia (GA). The choice between these two techniques is largely institution based. Currently in the Saskatoon Health Region (SHR) endovascular thrombectomies are performed under general anesthesia due to operator preference and the optimization of surgical conditions. In the United States and other Canadian centers, this procedure is performed safely with local anesthesia with or without sedation.

Several retrospective trials have suggested that general anesthetics are associated with poorer outcomes. It has been suggested that general anesthesia can result in a delay in the time to procedural start since it requires the presence of an anesthesiologist and the procedure can be performed under sedation without extra personnel. It is also proposed that the induction of general anesthesia can cause a decrease in blood pressure and a decrease in collateral perfusion which can result in further cellular hypoxia. Anesthesiologists , however, are able to expertly manipulate hemodynamic parameters during general anesthesia to the specific requirements of the operators potentially creating optimal tissue oxygenation conditions.

There is a need for a prospective trial to assess the effect of general anesthetic on patient outcome during endovascular thrombectomy. At this time, it is premature to conduct a randomized controlled trial (RCT). Therefore in this pilot study, adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will receive a general anesthetic as per their current practice, and their data will be collected prospectively. This cohort of participants will then be compared to participants that underwent the same procedure in another study, who received local anesthesia with sedation. Approximately 77 prospective participants will be recruited for the prospective arm of this study.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will be prospectively recruited for the prospective arm.
Condition
  • Stroke
  • Cerebrovascular Stroke
  • Brain Ischemia
  • Brain Diseases
  • Cardiovascular Diseases
  • Central Nervous System Diseases
  • Cerebrovascular Disorders
  • Nervous System Diseases
  • Vascular Diseases
Intervention
  • Drug: Sevoflurane
  • Drug: Lidocaine
Study Groups/Cohorts
  • Prospective - General Anesthetic
    The prospective treatment group will have an anesthetic induction according to the anesthetic provider's preference that will include propofol and fentanyl as IV induction agents and rocuronium as a muscle paralytic. Maintenance of anesthesia for the treatment group will include sevoflurane with a target end tidal concentration of 1-1.5%, rocuronium as a paralytic as needed, opioids and any other standard medication deemed necessary by the provider.
    Intervention: Drug: Sevoflurane
  • Retrospective - Local Anesthetic with Sedation
    The retrospective group will have received local anesthetic from the surgeon using lidocaine injected subcutaneously and received sedation using fentanyl and midazolam as needed to achieve the desired level of sedation.
    Intervention: Drug: Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 22, 2015)
77
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Acute ischemic stroke
  • Age 18 or greater
  • Onset (last seen well) time to treatment less than 12 hours
  • Disabling stroke defined as a baseline NIHSS > 5 at the time of treatment
  • Pre-stroke independent functional status in activities of daily living. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required
  • Pre-enrollment non-intubated state based on acceptable GCS for the prospective Cohort
  • Small core proximal occlusion as confirmed by CT angiography (carotid, M1 MCA or M1 MCA equivalent)
  • Intention to initiate endovascular treatment within 60 minutes of baseline non-contrast CT
  • Sevoflurane used during thrombectomy
  • Appropriate consent provided

Exclusion Criteria:

  • Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion
  • Hemorrhagic stroke
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
  • Intubated state based on GCS at any time prior to induction of general anesthesia for prospective cohort
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02639806
Other Study ID Numbers SEVO-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Kelly, University of Saskatchewan
Study Sponsor University of Saskatchewan
Collaborators University of Calgary
Investigators
Principal Investigator: Michael Kelly, MD, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2019