General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

NCT02639806 | Completed

• 1 other identifier: SEVO-01
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the outcomes of stroke patients treated for intravascular thrombectomy, using either a local anesthetic with sedation, or a general anesthetic. Historical data will be used for those treated with the local anesthetic, and prospective data will be used for those treated with the general anesthetic.

Conditions

Stroke; Cerebrovascular Stroke; Brain Ischemia; Brain Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Nervous System Diseases; Vascular Diseases

Keywords

stroke; endovascular; thrombectomy; ischemic stroke; general anesthetic; local anesthetic; recanalization

Outcome Measures

Primary Outcomes (1)

• Shift in the mRS score, defined by a proportional odds model.

  90 Days

Secondary Outcomes (6)

• The proportion of patients who achieve a NIHSS score 0-2

  90 Days

• The proportion of patients who achieve a mRS 0-2

  90 days

• Recanalization of the target arterial occlusive lesion

  Day 0

• Time from diagnostic CT to procedure initiation

  Day 0

• Time from the start of the procedure to vascular recanalization

  Day 0

Study Arms (2)

Prospective - General Anesthetic

The prospective treatment group will have an anesthetic induction according to the anesthetic provider's preference that will include propofol and fentanyl as IV induction agents and rocuronium as a muscle paralytic. Maintenance of anesthesia for the treatment group will include sevoflurane with a target end tidal concentration of 1-1.5%, rocuronium as a paralytic as needed, opioids and any other standard medication deemed necessary by the provider.

Drug: Sevoflurane

Retrospective - Local Anesthetic with Sedation

The retrospective group will have received local anesthetic from the surgeon using lidocaine injected subcutaneously and received sedation using fentanyl and midazolam as needed to achieve the desired level of sedation.

Drug: Lidocaine

Interventions

Sevoflurane DRUG

Prospective - General Anesthetic

Lidocaine DRUG

Retrospective - Local Anesthetic with Sedation

Eligibility Criteria

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

Study Population

Adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will be prospectively recruited for the prospective arm.

You may qualify if:

• Acute ischemic stroke
• Age 18 or greater
• Onset (last seen well) time to treatment less than 12 hours
• Disabling stroke defined as a baseline NIHSS \> 5 at the time of treatment
• Pre-stroke independent functional status in activities of daily living. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required
• Pre-enrollment non-intubated state based on acceptable GCS for the prospective Cohort
• Small core proximal occlusion as confirmed by CT angiography (carotid, M1 MCA or M1 MCA equivalent)
• Intention to initiate endovascular treatment within 60 minutes of baseline non-contrast CT
• Sevoflurane used during thrombectomy
• Appropriate consent provided

You may not qualify if:

• Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion
• Hemorrhagic stroke
• Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
• Intubated state based on GCS at any time prior to induction of general anesthesia for prospective cohort

Sponsors & Collaborators

• University of Saskatchewan: lead
• University of Calgary: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Stroke; Brain Ischemia; Brain Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Nervous System Diseases; Vascular Diseases; Ischemic Stroke

Interventions

Sevoflurane; Lidocaine

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Michael Kelly, MD, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PHD

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 24, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

CA (1)