General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

Completed

• Conditions: Cardiovascular Diseases; Central Nervous System Diseases; Stroke; Brain Diseases; Vascular Diseases; Cerebrovascular Stroke; Nervous System Diseases; Brain Ischemia; Cerebrovascular Disorders
• Interventions: Drug: Sevoflurane; Drug: Lidocaine

• Registration Number: NCT02639806
• Lead Sponsor: University of Saskatchewan

Brief Summary

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.

Study Timeline

• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-24
• Study Start: 2016-01
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective - General Anesthetic	Sevoflurane	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	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Shift in the mRS score, defined by a proportional odds model.	90 Days

Secondary Outcome Measures

Name	Time	Method
The proportion of patients who achieve a NIHSS score 0-2	90 Days	Stroke severity. Clinical scale outcome score from 0 to 42.
Time from diagnostic CT to procedure initiation	Day 0
Recanalization of the target arterial occlusive lesion	Day 0	Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.
Time from the start of the procedure to vascular recanalization	Day 0
The proportion of patients who achieve a mRS 0-2	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.
Incidence of Treatment-Emergent Adverse Events	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

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada