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

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ClinicalTrials.gov Identifier: NCT02677415
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
modified Rankin score [ Time Frame: post-procedural 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment
Official Title  ICMJE Impact of General vs Local Anesthesia on Neurological Function in Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Stroke
Intervention  ICMJE
  • Other: Intravenous anesthetics
  • Other: local anesthesia
  • Other: Controlled ventilation
  • Other: Spontaneous breathing
Study Arms  ICMJE
  • Local anesthesia
    local anesthesia and spontaneous breathing will be maintained.
    Interventions:
    • Other: local anesthesia
    • Other: Spontaneous breathing
  • General anesthesia
    Intravenous anesthetics and controlled ventilation will be used .
    Interventions:
    • Other: Intravenous anesthetics
    • Other: Controlled ventilation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
640
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ruquan Han, M.D., Ph.D. 8610-67096660 ruquan.han@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02677415
Other Study ID Numbers  ICMJE QML20150508
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yuming Peng, Beijing Tiantan Hospital
Study Sponsor  ICMJE Beijing Tiantan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruquan Han, M.D., Ph.D. Department of Anesthesiology, Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP