Clinical trial NCT07001267: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke Patients
Keywords: Inhalation anesthesia
Intravenous anesthesia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

* \>18 years Acute ischemic stroke requiring endovascular treatment.

Exclusion Criteria:

* \<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

Primary outcomes:
measure: Functional Independence at 90 days
timeFrame: From enrollment to 90 days after treatment
Secondary outcomes:
measure: Comparison of National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: From enrollment to 90 days after treatment
measure: Thrombolysis in Cerebral Infarction (TICI) score
timeFrame: From enrollment to 90 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Arun George, MD
role: PRINCIPAL_INVESTIGATOR
References: