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CANVAS: Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02677415
Collaborator
(none)
640
Enrollment
1
Location
2
Arms
75
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intravenous anesthetics
  • Other: local anesthesia
  • Other: Controlled ventilation
  • Other: Spontaneous breathing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Local anesthesia

local anesthesia and spontaneous breathing will be maintained.

Other: local anesthesia

Other: Spontaneous breathing
Other: General anesthesia

Intravenous anesthetics and controlled ventilation will be used .

Other: Intravenous anesthetics

Other: Controlled ventilation

Outcome Measures

Primary Outcome Measures

  1. modified Rankin score [post-procedural 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing TianTan Hospital Beijing China 100050

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuming Peng, M.D., Ph.D., Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT02677415
Other Study ID Numbers:
  • QML20150508
First Posted:
Feb 9, 2016
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Yuming Peng, M.D., Ph.D., Beijing Tiantan Hospital
Ischemic Stroke
Anesthesia
Endovascular Procedures
Additional relevant MeSH terms:
Stroke
Ischemic Stroke
Anesthetics
Anesthetics, Intravenous

Study Results

No Results Posted as of Sep 14, 2021