NCT02677415

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

6.3 years

First QC Date

February 5, 2016

Last Update Submit

September 12, 2021

Conditions

Acute Stroke

Keywords

Ischemic StrokeAnesthesiaEndovascular Procedures

Outcome Measures

Primary Outcomes (1)

  • modified Rankin score

    post-procedural 30 days

Study Arms (2)

Local anesthesia

OTHER

local anesthesia and spontaneous breathing will be maintained.

Other: local anesthesiaOther: Spontaneous breathing

General anesthesia

OTHER

Intravenous anesthetics and controlled ventilation will be used .

Other: Intravenous anestheticsOther: Controlled ventilation

Interventions

Intravenous anestheticsOTHER
General anesthesia
local anesthesiaOTHER
Local anesthesia
Controlled ventilationOTHER
General anesthesia
Spontaneous breathingOTHER
Local anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with AIS scheduled to receive emergency endovascular treatment, older than 18; the onset time is within 12 hours.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing TianTan Hospital

Beijing, 100050, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35857365DERIVED

  • 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.

    PMID: 28436307DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Anesthetics, IntravenousAnesthesia, Local

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthetics, GeneralAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Ruquan Han, M.D., Ph.D.

    Department of Anesthesiology, Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruquan Han, M.D., Ph.D.

CONTACT

8610-67096660ruquan.han@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

CN(1)