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

NCT ID: NCT02677415

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Local anesthesia

local anesthesia and spontaneous breathing will be maintained.

Group Type OTHER

local anesthesia

Intervention Type OTHER

Spontaneous breathing

Intervention Type OTHER

General anesthesia

Intravenous anesthetics and controlled ventilation will be used .

Group Type OTHER

Intravenous anesthetics

Intervention Type OTHER

Controlled ventilation

Intervention Type OTHER

Interventions

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Intravenous anesthetics

Intervention Type OTHER

local anesthesia

Intervention Type OTHER

Controlled ventilation

Intervention Type OTHER

Spontaneous breathing

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuming Peng

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Beijing Tiantan Hospital

Locations

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Beijing TianTan Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

8610-67096660

Facility Contacts

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Ruquan Han, M.D., Ph.D

Role: primary

8610-67096660

References

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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.

Reference Type DERIVED
PMID: 35857365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28436307 (View on PubMed)

Other Identifiers

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QML20150508

Identifier Type: -

Identifier Source: org_study_id

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