General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
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|ClinicalTrials.gov Identifier: NCT02639806|
Recruitment Status : Unknown
Verified June 2016 by Michael Kelly, University of Saskatchewan.
Recruitment status was: Enrolling by invitation
First Posted : December 24, 2015
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment|
|Stroke Cerebrovascular Stroke Brain Ischemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases||Drug: Sevoflurane Drug: Lidocaine|
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|
|Estimated Enrollment :||77 participants|
|Official Title:||General Anesthesia for Endovascular Thrombectomy; A Pilot Study.|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
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.
- Shift in the mRS score, defined by a proportional odds model. [ Time Frame: 90 Days ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639806
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Michael Kelly, MD, PhD||University of Saskatchewan|