Acute StrokeCANVASNCT02677415
Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment
A study testing Intravenous anesthetics, local anesthesia and Spontaneous breathing in people with Acute Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Recent observational studies have found an association between general anaesthesia and increased post-operative mortality in acute ischemic stroke patients undergoing endovascular treatment. It is unknown whether there is a causal relationship in this observation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Intravenous anesthetics, local anesthesia and Spontaneous breathing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 12 hours.
Who cannot join
- Radiological ambiguity concerning infarction and vessel occlusion.
- Additional intracerebral hemorrhage.
- Posterior circulation infraction.
- Coma on admission (Glasgow coma score less than 8).
- NIHSS less than 10 or more than 35.
- Severe agitation or seizures on admission.
Show all 9Show fewer
- Obvious loss of airway protective reflexes and/or vomiting on admission.
- Being intubated before treatment on admission.
- Known allergy to anesthetic or analgesic.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing TianTan Hospital
Beijing, 100050
Ruquan Han, M.D., Ph.D, 8610-67096660, ruquan.han@gmail.com
About this study
Official title: Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment
Recent observational studies have found an association between general anaesthesia and increased post-operative mortality in acute ischemic stroke patients undergoing endovascular treatment. It is unknown whether there is a causal relationship in this observation. The investigators are performing a large randomised trial of general versus local anaesthesia to definitively answer the question of whether anaesthetic type alters perioperative outcome.
- Conditions
- Acute Stroke
- Being tested
- Intravenous anesthetics, local anesthesia, Controlled ventilation, Spontaneous breathing
- Keywords
- Ischemic Stroke, Anesthesia, Endovascular Procedures
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous anestheticsOther
local anesthesiaOther
Controlled ventilationOther
Spontaneous breathingOther
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia | Other | local anesthesia and spontaneous breathing will be maintained. Receives: Other: local anesthesia; Other: Spontaneous breathing |
| General anesthesia | Other | Intravenous anesthetics and controlled ventilation will be used . Receives: Other: Intravenous anesthetics; Other: Controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin score
Measured: post-procedural 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph.D., Principal investigator, Department of Anesthesiology, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677415
- Sponsor's protocol ID
- QML20150508
- Acronym
- CANVAS
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2016
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
PubMed 35857365Peng Y, Li Y, Jian M, Liu X, Sun J, Jia B, Dong J, Zeng M, Lin N, Zhang L, Gelb AW, Chan MT, Han R. Choice of ANesthesia for EndoVAScular Treatment of Acute Ischemic Stroke: Protocol for a randomized controlled (CANVAS) trial. Int J Stroke. 2017 Dec;12(9):991-997. doi: 10.1177/1747493017706243. Epub 2017 Apr 24.
PubMed 28436307
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment
- ClinicalTrials.gov ID
- NCT02677415
- Acronym / sponsor ID
- CANVAS / QML20150508
- Conditions
- Acute Stroke
- Keywords
- Ischemic Stroke, Anesthesia, Endovascular Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Feb 2016 (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.
Recent observational studies have found an association between general anaesthesia and increased post-operative mortality in acute ischemic stroke patients undergoing endovascular treatment. It is unknown whether there is a causal relationship in this observation. The investigators are performing a large randomised trial of general versus local anaesthesia to definitively answer the question of whether anaesthetic type alters perioperative outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia | Other | Other: local anesthesia, Other: Spontaneous breathinglocal anesthesia and spontaneous breathing will be maintained. |
| General anesthesia | Other | Other: Intravenous anesthetics, Other: Controlled ventilationIntravenous anesthetics and controlled ventilation will be used . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 12 hours.
Key exclusion criteria (9 listed)
- Radiological ambiguity concerning infarction and vessel occlusion.
- Additional intracerebral hemorrhage.
- Posterior circulation infraction.
- Coma on admission (Glasgow coma score less than 8).
- NIHSS less than 10 or more than 35.
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 |
|---|---|---|
| Intravenous anesthetics | Other | General anesthesia |
| local anesthesia | Other | Local anesthesia |
| Controlled ventilation | Other | General anesthesia |
| Spontaneous breathing | Other | Local anesthesia |
Primary outcome
modified Rankin score
Time frame: post-procedural 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 35857365Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
- Derived from this study: PubMed 28436307Peng Y, Li Y, Jian M, Liu X, Sun J, Jia B, Dong J, Zeng M, Lin N, Zhang L, Gelb AW, Chan MT, Han R. Choice of ANesthesia for EndoVAScular Treatment of Acute Ischemic Stroke: Protocol for a randomized controlled (CANVAS) trial. Int J Stroke. 2017 Dec;12(9):991-997. doi: 10.1177/1747493017706243. Epub 2017 Apr 24.
- Individual participant dataSharing planned: Undecided
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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.
Ruquan Han, M.D., Ph.D. principal investigator
Department of Anesthesiology, Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous anesthetics, local anesthesia and Spontaneous breathing in people with Acute Stroke, run by Beijing Tiantan Hospital at 1 site in China.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Sep 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D., Ph.D. (8610-67096660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin score (time frame: post-procedural 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677415, which also lists 2 linked publications.
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 14 Sep 2021.