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

This study is currently recruiting participants.
Verified March 2017 by Yuming Peng, Beijing Tiantan Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02677415
First Posted: February 9, 2016
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital
  Purpose
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 Intervention
Acute Stroke Other: Intravenous anesthetics Other: local anesthesia Other: Controlled ventilation Other: Spontaneous breathing

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yuming Peng, Beijing Tiantan Hospital:

Primary Outcome Measures:
  • modified Rankin score [ Time Frame: post-procedural 30 days ]

Estimated Enrollment: 640
Actual Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Local anesthesia
local anesthesia and spontaneous breathing will be maintained.
Other: local anesthesia Other: Spontaneous breathing
General anesthesia
Intravenous anesthetics and controlled ventilation will be used .
Other: Intravenous anesthetics Other: Controlled ventilation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 6 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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677415


Contacts
Contact: Ruquan Han, M.D., Ph.D. 8610-67096660 ruquan.han@gmail.com

Locations
China
Beijing TianTan Hospital Recruiting
Beijing, China, 100050
Contact: Ruquan Han, M.D., Ph.D    8610-67096660    ruquan.han@gmail.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
Principal Investigator: Ruquan Han, M.D., Ph.D. Department of Anesthesiology, Beijing Tiantan Hospital
  More Information

Responsible Party: Yuming Peng, M.D., Ph.D., Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02677415     History of Changes
Other Study ID Numbers: QML20150508
First Submitted: February 5, 2016
First Posted: February 9, 2016
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yuming Peng, Beijing Tiantan Hospital:
Ischemic Stroke
Anesthesia
Endovascular Procedures

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General