General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

Enrolling by invitation

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Lidocaine Drug
    ARM 1: Kind: Experimental
    Label: Retrospective - Local Anesthetic with Sedation
    Description: 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.
  • Sevoflurane Drug
    ARM 1: Kind: Experimental
    Label: Prospective - General Anesthetic
    Description: 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.

Trial Design

  • Observation: Cohort
  • Sampling: Probability Sample

Trial Population

Adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will be prospectively recruited for the prospective arm.

Outcomes

Type Measure Time Frame Safety Issue
Primary Shift in the mRS score, defined by a proportional odds model. 90 Days No
Secondary The proportion of patients who achieve a NIHSS score 0-2 90 Days No
Secondary Reduced infarct volume as measured by post-procedure imaging 24-48 hrs No
Secondary The proportion of patients who achieve a mRS 0-2 90 days No
Secondary Recanalization of the target arterial occlusive lesion Day 0 No
Secondary Time from diagnostic CT to procedure initiation Day 0 No
Secondary Time from the start of the procedure to vascular recanalization Day 0 No
Secondary Incidence of Treatment-Emergent Adverse Events 90 Days Yes

Sponsors