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

May 17, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital

Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation: a Randomized Controlled Exploratory Study (CANVAS-Ⅱ)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Fengtai, Beijing, China, 100070
        • Ruquan Han
    • Guizhou
      • Guiyang, Guizhou, China, 550014
        • Fan Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Local anesthesia/conscious sedation
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.
Procedure: Local anesthesia/concious sedation
Patients will be injected with propofol and remifentanil.
Procedure: Spontaneous breath
Patients will be kept spontaneous breath.
Other: General anesthesia
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.
Procedure: General anesthesia
Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.
Procedure: Controlled ventilation
Patient will be kept with controlled ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified rankin score（mRS）
Time Frame: post-procedural 90 days
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.
post-procedural 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Ruquan Han, M.D., Ph.D, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2018

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

October 15, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-10-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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