Back to resultsImpact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment (CANVAS)
Primary Purpose
Acute Stroke
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intravenous anesthetics
local anesthesia
Controlled ventilation
Spontaneous breathing
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Stroke focused on measuring Ischemic Stroke, Anesthesia, Endovascular Procedures
Eligibility Criteria
Inclusion Criteria:
- Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 12 hours.
Exclusion Criteria:
- 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.
- Obvious loss of airway protective reflexes and/or vomiting on admission.
- Being intubated before treatment on admission.
- Known allergy to anesthetic or analgesic.
Sites / Locations
- Beijing TianTan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Local anesthesia
General anesthesia
Arm Description
local anesthesia and spontaneous breathing will be maintained.
Intravenous anesthetics and controlled ventilation will be used .
Outcomes
Primary Outcome Measures
modified Rankin score
Secondary Outcome Measures
Full Information
NCT ID
NCT02677415
First Posted
February 5, 2016
Last Updated
September 12, 2021
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02677415
Brief Title
Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment
Acronym
CANVAS
Official Title
Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Ischemic Stroke, Anesthesia, Endovascular Procedures
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
640 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local anesthesia
Arm Type
Other
Arm Description
local anesthesia and spontaneous breathing will be maintained.
Arm Title
General anesthesia
Arm Type
Other
Arm Description
Intravenous anesthetics and controlled ventilation will be used .
Intervention Type
Other
Intervention Name(s)
Intravenous anesthetics
Intervention Type
Other
Intervention Name(s)
local anesthesia
Intervention Type
Other
Intervention Name(s)
Controlled ventilation
Intervention Type
Other
Intervention Name(s)
Spontaneous breathing
Primary Outcome Measure Information:
Title
modified Rankin score
Time Frame
post-procedural 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 12 hours.
Exclusion Criteria:
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.
Obvious loss of airway protective reflexes and/or vomiting on admission.
Being intubated before treatment on admission.
Known allergy to anesthetic or analgesic.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruquan Han, M.D., Ph.D.
Phone
8610-67096660
Email
ruquan.han@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D.
Organizational Affiliation
Department of Anesthesiology, Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing TianTan Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-67096660
Email
ruquan.han@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35857365
Citation
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.
Results Reference
derived
PubMed Identifier
28436307
Citation
Peng 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.
Results Reference
derived
Learn more about this trial
Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment
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