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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anesthesia drugs during the surgery.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Procedure Anesthesia drugs during the surgery
During treatment for acute ischemic stroke, patients will be given either inhalation or intravenous anesthesia.
Primary outcome measures
- Functional Independence at 90 days [Time frame: From enrollment to 90 days after treatment]
Secondary outcome measures (2)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT07001267 · STUDY00161241