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Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation (CANVAS-II)

Primary Purpose

Posterior Circulation Brain Infarction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
General anesthesia
Local anesthesia/concious sedation
Spontaneous breath
Controlled ventilation
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Posterior Circulation Brain Infarction focused on measuring Anesthesia Methods, Acute Ischemic Stroke, Endovascular Treatment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with acute ischemic stroke in posterior cerebral circulation scheduled to receive emergency endovascular treatment; Age > 18; The onset time is within 24 hours; Modified rankin score ≤2 before onset.

Exclusion Criteria:

  • Radiological ambiguity concerning infarction and vessel occlusion; Additional intracerebral hemorrhage; Anterior circulation infraction; Coma on admission (Glasgow coma score less than 8); NIHSS less than 6 or more than 30; 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

  • Ruquan Han
  • Fan Wang

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Local anesthesia/conscious sedation

General anesthesia

Arm Description

Patients will be injected by propofol (adjusted by bispectral index scale ≥70 ) and /or remifentanil（0.01-0.06μg/kg/min）. Patients will maintain spontaneous breathing.

Patients will be induced with remifentanil (0.2-0.8 μg/kg), propofol (1-2mg/kg) and rocuronium (0.6 mg/kg). Anesthesia will then be maintained keep the BIS between 40 and 60 with propofol and remifentanil. After tracheal intubation, patients will be kept with controlled ventilation.

Outcomes

Primary Outcome Measures

modified rankin score（mRS）
Modified rankin score（mRS）is used to evaluate the primary outcome. The scale of mRS is 0 to 6. The best neurological outcome is the mRS with 0, indicating no any symptom left, and a good neurological outcome is agreed with a mRS≤2. mRS of 6 is the worst, indicating death. mRS will be evaluated by outcomes assessor who is blinded to the grouping.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2017
Last Updated
May 17, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03317535
Brief Title
Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation
Acronym
CANVAS-II
Official Title
Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation: a Randomized Controlled Exploratory Study (CANVAS-Ⅱ)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2018 (Actual)
Primary Completion Date
June 23, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is few randomized controlled clinical to investigated the impact of anesthetic type on outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is unknown whether the choice of anesthesia is impacted on the outcomes for these patients or not. The investigators will perform a randomized controlled pilot clinical trial of general anesthesia versus local anesthesia/conscious sedation to explore and find out a potential fact whether anesthetic type alters perioperative neurological function in patients with acute ischemic stroke in posterior cerebral circulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Circulation Brain Infarction
Keywords
Anesthesia Methods, Acute Ischemic Stroke, Endovascular Treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthesia/conscious sedation
Arm Type
Other
Arm Description
Patients will be injected by propofol (adjusted by bispectral index scale ≥70 ) and /or remifentanil（0.01-0.06μg/kg/min）. Patients will maintain spontaneous breathing.
Arm Title
General anesthesia
Arm Type
Other
Arm Description
Patients will be induced with remifentanil (0.2-0.8 μg/kg), propofol (1-2mg/kg) and rocuronium (0.6 mg/kg). Anesthesia will then be maintained keep the BIS between 40 and 60 with propofol and remifentanil. After tracheal intubation, patients will be kept with controlled ventilation.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia/concious sedation
Intervention Description
Patients will be injected with propofol and remifentanil.
Intervention Type
Procedure
Intervention Name(s)
Spontaneous breath
Intervention Description
Patients will be kept spontaneous breath.
Intervention Type
Procedure
Intervention Name(s)
Controlled ventilation
Intervention Description
Patient will be kept with controlled ventilation.
Primary Outcome Measure Information:
Title
modified rankin score（mRS）
Description
Modified rankin score（mRS）is used to evaluate the primary outcome. The scale of mRS is 0 to 6. The best neurological outcome is the mRS with 0, indicating no any symptom left, and a good neurological outcome is agreed with a mRS≤2. mRS of 6 is the worst, indicating death. mRS will be evaluated by outcomes assessor who is blinded to the grouping.
Time Frame
post-procedural 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute ischemic stroke in posterior cerebral circulation scheduled to receive emergency endovascular treatment; Age > 18; The onset time is within 24 hours; Modified rankin score ≤2 before onset. Exclusion Criteria: Radiological ambiguity concerning infarction and vessel occlusion; Additional intracerebral hemorrhage; Anterior circulation infraction; Coma on admission (Glasgow coma score less than 8); NIHSS less than 6 or more than 30; 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruquan Han
City
Fengtai
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
Fan Wang
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550014
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36156704
Citation
Liang F, Wu Y, Wang X, Yan L, Zhang S, Jian M, Liu H, Wang A, Wang F, Han R; CANVAS II Group. General Anesthesia vs Conscious Sedation for Endovascular Treatment in Patients With Posterior Circulation Acute Ischemic Stroke: An Exploratory Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):64-72. doi: 10.1001/jamaneurol.2022.3018.
Results Reference
derived
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
32737091
Citation
Liang F, Zhao Y, Yan X, Wu Y, Li X, Zhou Y, Jian M, Li S, Miao Z, Han R, Peng Y. Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study. BMJ Open. 2020 Jul 31;10(7):e036358. doi: 10.1136/bmjopen-2019-036358.
Results Reference
derived

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Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation

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