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CompletedNCT03317535CANVAS-IIUpdated May 19, 2023

Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation

An interventional study of General anesthesia and Local anesthesia/concious sedation in Posterior Circulation Brain Infarction, sponsored by Beijing Tiantan Hospital. Completed at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Posterior Circulation Brain Infarction

Keywords

  • Anesthesia Methods
  • Acute Ischemic Stroke
  • Endovascular Treatment
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • 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 · Procedure: 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 · Procedure: Controlled ventilation

Interventions

  • ProcedureGeneral anesthesia

    Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.

  • ProcedureLocal anesthesia/concious sedation

    Patients will be injected with propofol and remifentanil.

  • ProcedureSpontaneous breath

    Patients will be kept spontaneous breath.

  • ProcedureControlled ventilation

    Patient will be kept with controlled ventilation.

05

What researchers measure

Primary outcomes

  1. modified rankin score（mRS）

    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.

    Time frame: post-procedural 90 days

06

Study locations

2 sites
  • Ruquan Han
    Fengtai, Beijing 100070, China
  • Fan Wang
    Guiyang, Guizhou 550014, China
07

References and documents

Publications

  • Liang F, Wu Y, Wang X, Yan L, Zhang S, Jian M, Liu H, Wang A, Wang F, Han R; CANVAS II Group. General Anesthesia vs Conscious Sedation for Endovascular Treatment in Patients With Posterior Circulation Acute Ischemic Stroke: An Exploratory Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):64-72. doi: 10.1001/jamaneurol.2022.3018. PubMed 36156704 ↗
  • 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. PubMed 35857365 ↗
  • Liang F, Zhao Y, Yan X, Wu Y, Li X, Zhou Y, Jian M, Li S, Miao Z, Han R, Peng Y. Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study. BMJ Open. 2020 Jul 31;10(7):e036358. doi: 10.1136/bmjopen-2019-036358. PubMed 32737091 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03317535
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Ruquan Han (Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Oct 23, 2017
Start date
Mar 18, 2018
Primary completion
Jun 23, 2021
Completion
Jun 23, 2021
Last update
May 19, 2023

Study contacts

Ruquan Han, M.D., Ph.D
principal investigator · Beijing Tiantan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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