Extended Emergence Trajectory on Post-Anesthesia Care Units Events in Ambulatory Lower-Extremity Orthopedic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to Meet Post Anesthesia Care Unit (PACU) Discharge Criteria
研究概览
简要总结
The goal of this clinical trial is to learn if an extended emergence from anesthesia can improve recovery room (Post-Anesthesia Care Unit or PACU) outcomes in lower-leg or foot surgery with nerve blocks. The primary questions it aims to answer are:
- Does a longer wake-up help participants think more clearly soon after surgery compared with usual approaches?
- Does it lower pain scores, lower the amount of pain medications used, and shorten the time it takes to go home from recovery room?
Researchers will compare 2 groups of adults who are having similar lower-extremity orthopaedic surgeries with regional and propofol anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for Elective Foot/Ankle Orthopaedic surgery at Stanford Health under planned propofol-based intravenous anesthesia and regional nerve block for preoperative analgesia
- •Able and willing to complete all cognitive assessments and Brice Interview in PACU
排除标准
- •ASA physical status IV or V
- •Chronic opioid therapy
- •Chronic benzodiazepine use or ongoing treatment with strongly anticholinergic medications within 30 days prior to surgery.
- •Known major neuro-cognitive disorder, active psychotic disorder, or other severe psychiatric condition that, in the opinion of the investigator, would interfere with valid cognitive testing.
- •Active cardiac or neurological stimulators or pumps in use
- •Severe uncorrected visual or hearing impairment that precludes valid cognitive battery or interview completion.
- •Inability to speak and understand the study language sufficiently to provide informed consent and complete study assessments.
- •Inability to provide informed consent or lack of a legally authorized representative when required.
- •Concurrent participation in another interventional study that could confound PACU cognitive or delirium outcomes.
研究组 & 干预措施
Foot and ankle surgery with extended EEG emergence trajectory
Participants undergoing routine foot and ankle surgery will be given an experimental EEG emergence trajectory at end-operation held at PSI greater than 50 for a minimum of 5 minutes.
干预措施: Extended EEG Emergence Trajectory (Procedure)
Foot and ankle surgery with standard of care EEG emergence
Participants undergoing routine foot and ankle surgery will be given a routine standard of care intraoperatively at standard Patient Status Index (PSI) readings.
干预措施: Standard of Care EEG-Guided Emergence (Procedure)
结局指标
主要结局
Time to Meet Post Anesthesia Care Unit (PACU) Discharge Criteria
时间窗: Up to 2-5 hours post-surgery with discharge criteria are met.
Study will measure time in minutes from PACU arrival to the first documentation of institutional PACU discharge criteria being met.
次要结局
未报告次要终点
研究者
Harrison Shong-Wen Chow
Clinical Professor in Medicine
Stanford University