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Completed

NCT Number: NCT02639806

General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Lidocaine

Drug

Primary outcomes

  1. Shift in the mRS score, defined by a proportional odds model.

    Time frame: 90 Days

Secondary outcomes

  1. 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.

  2. 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.

  3. Recanalization of the target arterial occlusive lesion

    Time frame: Day 0

    Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.

  4. Time from diagnostic CT to procedure initiation

    Time frame: Day 0

  5. Time from the start of the procedure to vascular recanalization

    Time frame: Day 0

  6. 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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • University of Calgary

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2015
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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