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

Not Applicable

• Conditions: Acute Stroke
• Interventions: Other: local anesthesia; Other: Intravenous anesthetics; Other: Controlled ventilation; Other: Spontaneous breathing

• Registration Number: NCT02677415
• Lead Sponsor: Beijing Tiantan Hospital

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 available

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Study Start: 2016-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-14
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local anesthesia	local anesthesia	local anesthesia and spontaneous breathing will be maintained.
General anesthesia	Controlled ventilation	Intravenous anesthetics and controlled ventilation will be used .
Local anesthesia	Spontaneous breathing	local anesthesia and spontaneous breathing will be maintained.
General anesthesia	Intravenous anesthetics	Intravenous anesthetics and controlled ventilation will be used .

Primary Outcome Measures

Name	Time	Method
modified Rankin score	post-procedural 30 days

Trial Locations

Locations (1)

Beijing TianTan Hospital; 🇨🇳 Beijing, China