Prospective Randomized Observer Blinded Single Center Study Comparing 90-day Functional Outcome in Patients Who Received Intravenous Propofol Infusion Versus Inhalational Sevoflurane for General Anesthesia During Mechanical Thrombectomy in Patients Who Suffered From Acute Ischemic Stroke
1 other identifier
interventional
120
1 country
1
Brief Summary
This study is being done to compare outcomes after surgery for individuals who receive anesthesia through by inhaling medication and individuals who receive anesthesia intravenously by needle when experiencing treatment for their stroke. Currently very little is known about the outcomes for patients when comparing these two techniques of providing anesthesia during surgery. This study will provide information regarding outcomes that will help health care providers decide which technique will be better for patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedStudy Start
First participant enrolled
June 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 12, 2026
March 1, 2026
2 years
May 23, 2025
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Independence at 90 days
The primary end point is functional independence at 90 days evaluated with the modified Rankin Scale (mRS). We plan to compare the functional recovery in 90 days in patients undergoing inhalational versus intravenous general anesthesia during mechanical thrombectomy using the modified Rankin score (mRS) in patients who suffered an acute ischemic stroke. (The mRS assesses a patient's functional independence or dependence after a stroke. Scores range from 0 (no symptoms) to 6 (death), with 0-2 indicating functional independence and 3-5 indicating dependence. A separate category of 6 is often added for patients who have died)
From enrollment to 90 days after treatment
Secondary Outcomes (2)
Comparison of National Institutes of Health Stroke Scale (NIHSS) score
From enrollment to 90 days after treatment
Thrombolysis in Cerebral Infarction (TICI) score
From enrollment to 90 days after treatment
Study Arms (2)
inhalational sevoflurane
ACTIVE COMPARATORWhen treated for acute ischemic stroke, patient will receive inhalation sevoflurane as anesthesia
intravenous propofol infusion
ACTIVE COMPARATORWhen treated for acute ischemic stroke, patient will receive intravenous propofol infusion as anesthesia
Interventions
During treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia.
Eligibility Criteria
You may qualify if:
- \>18 years Acute ischemic stroke requiring endovascular treatment.
You may not qualify if:
- \<18 years
- Pregnant patients
- Patients with malignant hyperthermia
- Allergies or any contraindications to either inhalational or intravenous agents
- Patients already on intravenous anesthetic infusions
- Prisoners
- Students and employees
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Arun George, MD
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 3, 2025
Study Start
June 4, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share