Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

General Anesthesia for Endovascular Thrombectomy; A Pilot Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02639806
Recruitment Status : Unknown
Verified June 2016 by Michael Kelly, University of Saskatchewan.
Recruitment status was:  Enrolling by invitation
First Posted : December 24, 2015
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Michael Kelly, University of Saskatchewan

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.

Condition or disease Intervention/treatment
Stroke Cerebrovascular Stroke Brain Ischemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases Drug: Sevoflurane Drug: Lidocaine

Detailed Description:

This is an open-label pilot study, comparing intravascular thrombectomy patients treated using either general anesthetic (prospective arm) or local anesthetic with sedation (retrospective arm), with blinded outcome evaluation.

New evidence has established that the addition of endovascular thrombectomy for large, and/or proximal occlusions improves outcome in addition to, and/or in place of tPA therapy. There have been no randomized prospective trials assessing the relationship of anesthesia on outcomes for this procedure. This procedure is routinely performed under either local anesthetic with sedation and under general anesthesia (GA). The choice between these two techniques is largely institution based. Currently in the Saskatoon Health Region (SHR) endovascular thrombectomies are performed under general anesthesia due to operator preference and the optimization of surgical conditions. In the United States and other Canadian centers, this procedure is performed safely with local anesthesia with or without sedation.

Several retrospective trials have suggested that general anesthetics are associated with poorer outcomes. It has been suggested that general anesthesia can result in a delay in the time to procedural start since it requires the presence of an anesthesiologist and the procedure can be performed under sedation without extra personnel. It is also proposed that the induction of general anesthesia can cause a decrease in blood pressure and a decrease in collateral perfusion which can result in further cellular hypoxia. Anesthesiologists , however, are able to expertly manipulate hemodynamic parameters during general anesthesia to the specific requirements of the operators potentially creating optimal tissue oxygenation conditions.

There is a need for a prospective trial to assess the effect of general anesthetic on patient outcome during endovascular thrombectomy. At this time, it is premature to conduct a randomized controlled trial (RCT). Therefore in this pilot study, adult acute ischemic stroke participants who undergo intravascular thrombectomy in Saskatchewan will receive a general anesthetic as per their current practice, and their data will be collected prospectively. This cohort of participants will then be compared to participants that underwent the same procedure in another study, who received local anesthesia with sedation. Approximately 77 prospective participants will be recruited for the prospective arm of this study.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 77 participants
Observational Model: Cohort
Official Title: General Anesthesia for Endovascular Thrombectomy; A Pilot Study.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Shift in the mRS score, defined by a proportional odds model. [ Time Frame: 90 Days ]

Secondary Outcome Measures :
  1. The proportion of patients who achieve a NIHSS score 0-2 [ Time Frame: 90 Days ]
    Stroke severity. Clinical scale outcome score from 0 to 42.

  2. The proportion of patients who achieve a mRS 0-2 [ Time Frame: 90 days ]
    Functional outcome. Dichotomous outcome, reported as independent (mRS 0-2) vs dependence or death (mRS 3-6). In addition, shift analysis (proportional odds model) representing the odds of improvement within the scale with treatment.

  3. Recanalization of the target arterial occlusive lesion [ Time Frame: Day 0 ]
    Measured by fluoroscopy - Demonstrated during (or as part of) the procedure.

  4. Time from diagnostic CT to procedure initiation [ Time Frame: Day 0 ]
  5. Time from the start of the procedure to vascular recanalization [ Time Frame: Day 0 ]
  6. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 90 Days ]
    Episodes of hypo/hypertensive and bradycardic episodes that required the use of pharmacologic agent.; Symptomatic intracranial hemorrhage; Major bleeding; Contrast nephropathy; Malignant MCA infarction; Hemicraniectomy; Aspiration Pneumonia; Adverse airway event; other



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639806


Locations
Layout table for location information
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
University of Calgary
Investigators
Layout table for investigator information
Principal Investigator: Michael Kelly, MD, PhD University of Saskatchewan

Layout table for additonal information
Responsible Party: Michael Kelly, Professor, MD, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02639806     History of Changes
Other Study ID Numbers: SEVO-01
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016

Keywords provided by Michael Kelly, University of Saskatchewan:
stroke
endovascular
thrombectomy
ischemic stroke
general anesthetic
local anesthetic
recanalization

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cardiovascular Diseases
Ischemia
Vascular Diseases
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Brain Ischemia
Pathologic Processes
Anesthetics
Lidocaine
Sevoflurane
Anesthetics, Local
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation