Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Oswestry Disability Index (ODI) score
研究概览
简要总结
Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.
详细描述
100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC.
Participants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group.
Group 1: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.
Group 2: Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed
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
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lumbar stenosis to be decompressed over 1-3 segments
- •Ages 40-95
- •Appropriate for general anesthesia
排除标准
- •Planned significant nerve root retraction
- •Previous fusion operation
- •Unable to comply with follow up
- •Patients with daily morphine equivalents or more 100mg
- •Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components.
- •Patients with allergies to eggs, egg products, soybeans or soy products.
研究组 & 干预措施
General anesthesia
Patients under this group will be undergoing lumbar decompression surgery with general anesthesia:
General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.
干预措施: Propofol Injection (Drug)
Monitored Anesthetic Care (MAC)/Local
Patients under this group wil be undergoing limbar decompression surgery with Monitored Anesthetic care, (MAC)/Local.
Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed.
干预措施: Lidocaine Hydrochloride, Injectable (Drug)
结局指标
主要结局
Change in Oswestry Disability Index (ODI) score
时间窗: Basline through year 2
Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.
Change in patient reported pain
时间窗: Basline through year 2
Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.
次要结局
未报告次要终点
研究者
Todd Alamin
Professor
Stanford University