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GA vs. CS for Endovascular Stroke Therapy

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ClinicalTrials.gov Identifier: NCT03247998
Recruitment Status : Not yet recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Miguel Arango, Lawson Health Research Institute

Brief Summary:
After a stroke caused by a blockage (clot) in a blood vessel in the brain, patients may have the clot removed by threading a catheter from the groin up to the affected area of the brain. An anesthesiologist is involved in the patient's care during this procedure to maximize patient safety and procedural efficiency. The options for anesthesia for this procedure are general anesthesia (where the patient is unconscious) or sedation (where the patient is in a relaxed, calm, sleepy condition). Currently, it is unclear which of these anesthetic options contributes to the best patient outcome. The investigators would like to investigate whether or not one method of anesthesia (general or sedation) is better to use than the other when removing the clot.

Condition or disease Intervention/treatment Phase
Stroke Endovascular Repair Anesthesia Drug: General Anesthesia Drug: Conscious Sedation with Remifentanil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be two arms of this study. In the first arm, the patients who meet the inclusion criteria of the study will be randomized to receive general anesthesia during endovascular treatment for stroke. In the second arm of the study, patients will receive general sedation during endovascular treatment.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor who will analyze the outcome variables for this study (consciousness, motor function, sensation, speech, coordination, standard of care follow up assessments etc.) that may be impacted by choice of anesthesia/analgesia will be blinded to the treatment group of the participants to ensure unbiased reporting.
Primary Purpose: Treatment
Official Title: GASTROKE- the Effect of General Anesthesia Versus Sedation for Patients With Acute Ischemic STROKE Undergoing Endovascular Treatment on Three Month Morbidity and Mortality: a Feasibility Study.
Estimated Study Start Date : August 31, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: General Anesthesia

Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Choice of anesthetic for general anesthesia is dependent upon the patient condition and decision of the treating anesthesiologist (ketamine, propofol, fentanyl, midazolam,dexmedetomidine etc.). General Anesthesia Protocol: (Melinda J. Davis, Cynthia R. Campos-Herrera, & David P. Archer, 2012; Powers et al., 2015; Talke et al., 2014). Patient will be monitored in accordance with standard monitoring guidelines and the rest of the procedure will proceed in accordance with standard of care.

See Detailed Description for additional details and description of follow-up procedures.

Drug: General Anesthesia
Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Choice of anesthetic for general anesthesia is dependent upon the patient condition and decision of the treating anesthesiologist (ketamine, propofol, fentanyl, midazolam,dexmedetomidine etc.). Induction of general anesthesia will follow standard treatment methods (Davis et al, 2012, Powers et al. 2015 Talke et al. 2015). Patient monitoring and care will proceed in accordance with standard of care guidelines. Refer to Detailed Description section for complete protocol information.
Other Name: No other names

Experimental: Conscious Sedation with Remifentanil

Patients who have had a stroke and meet the inclusion criteria for the study will receive conscious during endovascular treatment. Sedation will be accomplished using Remifentanil: 0.01-0.06 micrograms/kilogram/minute, titrated to effect. (Janssen et al., 2016). Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Patient will be monitored in accordance with standard monitoring guidelines and the rest of the procedure will proceed in accordance with standard of care.

See Detailed Description for additional details and description of follow-up procedures.

Drug: Conscious Sedation with Remifentanil
Patients who have had a stroke and meet the inclusion criteria for the study will receive conscious during endovascular treatment. Sedation will be accomplished using Remifentanil: 0.01-0.06 micrograms/kilogram/minute, titrated to effect. (Janssen et al., 2016). Patient monitoring and care will proceed in accordance with standard of care guidelines. Refer to Detailed Description section for complete protocol information.
Other Name: No other names




Primary Outcome Measures :
  1. Randomization potential [ Time Frame: 20 weeks ]
    Total number of participants that have been recruited and the drop out rates. Recruitment goal is 20 patients within 20 weeks.


Secondary Outcome Measures :
  1. Number of participants that complete the recruitment procedure prior to start of endovascular treatment. [ Time Frame: 20 weeks ]
    These procedures include patient identification and baseline assessments such as patient co-morbidities, demographics, and pre-procedural anesthetic assessment.

  2. Length of time to complete/completeness of study-related assessments [ Time Frame: 1 year ]
    To assess the feasibility of obtaining completed follow up assessments with this patient population and the time it takes to accomplish this.



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Ages Eligible for Study:   19 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All patients with ischemic stroke who:

  • are greater than 18 years of age
  • considered to be a candidate for endovascular therapy by the London Health Sciences Stroke team
  • presenting within the first 8 hours after symptom onset EXCEPT THOSE for whom general anesthesia is thought to be clearly indicated or contraindicated, by the attending anesthesiologist.

Exclusion Criteria:

  • Patients in whom the attending anesthesiologist considered that there was a clear indication for either GA or sedation

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): NCT03247998


Contacts
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Contact: Miguel Arango 519-685-8500 ext 35571 miguel.arango@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Miguel Arango Lawson Health Research Institute

Publications:

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Responsible Party: Miguel Arango, Anesthesiologist, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03247998     History of Changes
Other Study ID Numbers: GA Stroke
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miguel Arango, Lawson Health Research Institute:
Stroke
endovascular repair
general anesthesia
conscious sedation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents