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

NCT ID: NCT07001267

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

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

Conditions

Acute Ischemic Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

inhalational sevoflurane

When treated for acute ischemic stroke, patient will receive inhalation sevoflurane as anesthesia

Group Type: ACTIVE_COMPARATOR

Anesthesia drugs during the surgery

Intervention Type: PROCEDURE

During treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia.

intravenous propofol infusion

When treated for acute ischemic stroke, patient will receive intravenous propofol infusion as anesthesia

Group Type: ACTIVE_COMPARATOR

Anesthesia drugs during the surgery

Intervention Type: PROCEDURE

During treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia.

Interventions

Anesthesia drugs during the surgery

During treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Arun George

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun George, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Central Contacts

Arun George, MD

Role: CONTACT

ageorge9@kumc.edu

913-588-6670

Other Identifiers

STUDY00161241

Identifier Type: -

Identifier Source: org_study_id