StrokeNCT02639806
General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
An observational study of Stroke and Cerebrovascular Stroke, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Stroke, Brain Ischemia
- What is being tested?
- Sevoflurane and Lidocaine
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will be prospectively recruited for the prospective arm.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Stroke, Cerebrovascular Stroke, Brain Ischemia, Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases
- Being tested
- Sevoflurane, Lidocaine
- Keywords
- stroke, endovascular, thrombectomy, ischemic stroke, general anesthetic, local anesthetic, recanalization
- Medical subject headings
- Stroke, Brain Ischemia, Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Nervous System Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift in the mRS score, defined by a proportional odds model.
Measured: 90 Days
Secondary outcomes (6)
The proportion of patients who achieve a NIHSS score 0-2
Stroke severity. Clinical scale outcome score from 0 to 42.
Measured: 90 Days
The proportion of patients who achieve a mRS 0-2
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.
Measured: 90 days
Recanalization of the target arterial occlusive lesion
Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.
Measured: Day 0
Time from diagnostic CT to procedure initiation
Measured: Day 0
Time from the start of the procedure to vascular recanalization
Measured: Day 0
Incidence of Treatment-Emergent Adverse Events
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
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Michael Kelly, University of Saskatchewan
- Investigators
- Michael Kelly, MD, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639806
- Sponsor's protocol ID
- SEVO-01
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2015
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
- ClinicalTrials.gov ID
- NCT02639806
- Acronym / sponsor ID
- SEVO-01
- Conditions
- Stroke, Cerebrovascular Stroke, Brain Ischemia, Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases
- Keywords
- stroke, endovascular, thrombectomy, ischemic stroke, general anesthetic, local anesthetic, recanalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective - General Anesthetic | – | Drug: SevofluraneThe 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 | – | Drug: LidocaineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will be prospectively recruited for the prospective arm.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane | Drug | Prospective - General Anesthetic |
| Lidocaine | Drug | Retrospective - Local Anesthetic with Sedation |
Primary outcome
Shift in the mRS score, defined by a proportional odds model.
Time frame: 90 Days
6 secondary outcomes
The proportion of patients who achieve a NIHSS score 0-2
Time frame: 90 Days
The proportion of patients who achieve a mRS 0-2
Time frame: 90 days
Recanalization of the target arterial occlusive lesion
Time frame: Day 0
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kelly, MD, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebrovascular Stroke, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift in the mRS score, defined by a proportional odds model. (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.