General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
NCT ID: NCT02639806
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2016-01-31
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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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.
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.
Lidocaine
Interventions
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Sevoflurane
Lidocaine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
University of Saskatchewan
OTHER
Responsible Party
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Michael Kelly
Professor, MD, PHD
Principal Investigators
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Michael Kelly, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
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Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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SEVO-01
Identifier Type: -
Identifier Source: org_study_id