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

NCT03317535 | Completed DMC

• 1 other identifier: 2017-10-15
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Posterior Circulation Brain Infarction

Keywords

Anesthesia Methods; Acute Ischemic Stroke; Endovascular Treatment

Outcome Measures

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.

  post-procedural 90 days

Study Arms (2)

Local anesthesia/conscious sedation

OTHER

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

General anesthesia

OTHER

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

General anesthesia PROCEDURE

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

General anesthesia

Local anesthesia/concious sedation PROCEDURE

Patients will be injected with propofol and remifentanil.

Local anesthesia/conscious sedation

Spontaneous breath PROCEDURE

Patients will be kept spontaneous breath.

Local anesthesia/conscious sedation

Controlled ventilation PROCEDURE

Patient will be kept with controlled ventilation.

General anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (2)

Ruquan Han

Fengtai, Beijing Municipality, 100070, China

Location

Fan Wang

Guiyang, Guizhou, 550014, China

Location

Related Publications (3)

• 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.

  PMID: 36156704 DERIVED

• 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: 35857365 DERIVED

• 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.

  PMID: 32737091 DERIVED

MeSH Terms

Conditions

Brain Infarction; Ischemic Stroke

Interventions

Anesthesia, General; Anesthesia, Local

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Officials

• Ruquan Han, M.D., Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 23, 2017
• Study Start: March 18, 2018
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

CN (2)