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GA vs. CS for Endovascular Stroke Therapy

NCT03247998 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-14

No results posted yet for this study

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.

Conditions

  • Stroke
  • Endovascular Repair
  • Anesthesia

Interventions

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.

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.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Miguel Arango · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2019-08-01
Completion
2019-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247998 on ClinicalTrials.gov