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

University of Kansas

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke Patients

Treatments: Procedure: Anesthesia drugs during the surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07001267

STUDY00161241

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

inhalational sevoflurane

Active Comparator group

Description:

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

Treatment:

Procedure: Anesthesia drugs during the surgery

intravenous propofol infusion

Active Comparator group

Description:

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

Treatment:

Procedure: Anesthesia drugs during the surgery