Acute Ischemic Stroke PatientsNCT07001267
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
A study testing Anesthesia drugs during the surgery in people with Acute Ischemic Stroke Patients, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke Patients
- What is being tested?
- Anesthesia drugs during the surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years Acute ischemic stroke requiring endovascular treatment.
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Arun George, MD, 913-588-6670, ageorge9@kumc.edu
About this study
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
Read the detailed description
According to the National Center for Health Statistics, stroke is a leading cause of disability and in 2021 the number five cause of death in the United States1. Endovascular thrombectomy for patients experiencing acute ischemic stroke from the occlusion of a larger cerebral vessel has become a mainstay of treatment.2 Patients undergoing thrombectomy have significantly reduced disability when compared to patients who do not receive this therapy. Several studies have compared outcomes of patients receiving local anesthesia only or sedation versus general anesthesia during endovascular thrombectomy treatment.3,4 While questions remain, current consensus is that when these procedures are done on patients under general anesthesia, there are higher rates of recanalization (opening of the occluded blood vessel) and improved functional recovery. Currently, less is known about the impact of the general anesthesia technique (inhalation vs. intravenous) on disability and functional outcomes in stroke patients.
Aim: The aim of this study is to compare functional outcomes and disability in patients undergoing endovascular thrombectomy for acute ischemic stroke under general anesthesia using a volatile inhalational versus total intravenous anesthesia (TIVA) technique. Hypothesis: We hypothesize that patients receiving total intravenous anesthesia will have better functional outcomes and less disability compared to those receiving volatile inhalational anesthesia as measured by the 90 day modified Rankin score and compared in both groups.
Background and Significance
- Conditions
- Acute Ischemic Stroke Patients
- Being tested
- Anesthesia drugs during the surgery
- Keywords
- Inhalation anesthesia, Intravenous anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia drugs during the surgeryProcedure or surgery
During treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| inhalational sevoflurane | Active comparator | When treated for acute ischemic stroke, patient will receive inhalation sevoflurane as anesthesia Receives: Procedure: Anesthesia drugs during the surgery |
| intravenous propofol infusion | Active comparator | When treated for acute ischemic stroke, patient will receive intravenous propofol infusion as anesthesia Receives: Procedure: Anesthesia drugs during the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to 90 days after treatment
Secondary outcomes (2)
Comparison of National Institutes of Health Stroke Scale (NIHSS) score
Comparison of National Institutes of Health Stroke Scale (NIHSS) score at presentation and at 90 days between study groups.
Measured: From enrollment to 90 days after treatment
Thrombolysis in Cerebral Infarction (TICI) score
Thrombolysis in Cerebral Infarction (TICI) score comparison between study groups
Measured: From enrollment to 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start4 Jun 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun George, University of Kansas Medical Center
- Investigators
- Arun George, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001267
- Sponsor's protocol ID
- STUDY00161241
- Status last verified
- Mar 2026
- First submitted
- 23 May 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07001267
- Acronym / sponsor ID
- STUDY00161241
- Conditions
- Acute Ischemic Stroke Patients
- Keywords
- Inhalation anesthesia, Intravenous anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
According to the National Center for Health Statistics, stroke is a leading cause of disability and in 2021 the number five cause of death in the United States1. Endovascular thrombectomy for patients experiencing acute ischemic stroke from the occlusion of a larger cerebral vessel has become a mainstay of treatment.2 Patients undergoing thrombectomy have significantly reduced disability when compared to patients who do not receive this therapy. Several studies have compared outcomes of patients receiving local anesthesia only or sedation versus general anesthesia during endovascular thrombectomy treatment.3,4 While questions remain, current consensus is that when these procedures are done on patients under general anesthesia, there are higher rates of recanalization (opening of the occluded blood vessel) and improved functional recovery. Currently, less is known about the impact of the general anesthesia technique (inhalation vs. intravenous) on disability and functional outcomes in stroke patients.
Aim: The aim of this study is to compare functional outcomes and disability in patients undergoing endovascular thrombectomy for acute ischemic stroke under general anesthesia using a volatile inhalational versus total intravenous anesthesia (TIVA) technique. Hypothesis: We hypothesize that patients receiving total intravenous anesthesia will have better functional outcomes and less disability compared to those receiving volatile inhalational anesthesia as measured by the 90 day modified Rankin score and compared in both groups.
Background and Significance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhalational sevoflurane | Active comparator | Procedure: Anesthesia drugs during the surgeryWhen treated for acute ischemic stroke, patient will receive inhalation sevoflurane as anesthesia |
| intravenous propofol infusion | Active comparator | Procedure: Anesthesia drugs during the surgeryWhen treated for acute ischemic stroke, patient will receive intravenous propofol infusion as anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years Acute ischemic stroke requiring endovascular treatment.
Key exclusion criteria (7 listed)
- <18 years
- Pregnant patients
- Patients with malignant hyperthermia
- Allergies or any contraindications to either inhalational or intravenous agents
- Patients already on intravenous anesthetic infusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia drugs during the surgeryDuring treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia. | Procedure or surgery | inhalational sevoflurane, intravenous propofol infusion |
Primary outcome
Functional Independence at 90 days
Time frame: From enrollment to 90 days after treatment
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)
2 secondary outcomes
Comparison of National Institutes of Health Stroke Scale (NIHSS) score
Time frame: From enrollment to 90 days after treatment
Thrombolysis in Cerebral Infarction (TICI) score
Time frame: From enrollment to 90 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arun George, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia drugs during the surgery in people with Acute Ischemic Stroke Patients, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arun George, MD (913-588-6670, ageorge9@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence at 90 days (time frame: From enrollment to 90 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.