General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

December 7, 2023 updated by: Michael Kelly, University of Saskatchewan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Drug: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shift in the mRS score, defined by a proportional odds model.
Time Frame: 90 Days
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 Days
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.
90 days
Recanalization of the target arterial occlusive lesion
Time Frame: Day 0
Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.
Day 0
Time from diagnostic CT to procedure initiation
Time Frame: Day 0
Day 0
Time from the start of the procedure to vascular recanalization
Time Frame: Day 0
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
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

University of Calgary

Investigators

  • Principal Investigator: Michael Kelly, MD, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimated)

December 24, 2015

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEVO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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