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临床试验/NCT07001267
NCT07001267招募中不适用

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 Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Functional Independence at 90 days

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years Acute ischemic stroke requiring endovascular treatment.

排除标准

  • <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

研究组 & 干预措施

inhalational sevoflurane

Active Comparator

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

干预措施: Anesthesia drugs during the surgery (Procedure)

intravenous propofol infusion

Active Comparator

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

干预措施: Anesthesia drugs during the surgery (Procedure)

结局指标

主要结局

Functional Independence at 90 days

时间窗: 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)

次要结局

  • Comparison of National Institutes of Health Stroke Scale (NIHSS) score(From enrollment to 90 days after treatment)
  • Thrombolysis in Cerebral Infarction (TICI) score(From enrollment to 90 days after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arun George

Principal Investigator

University of Kansas Medical Center

研究点 (1)

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