Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage of Participants With 20+% Cerebral Desaturation Events
研究概览
简要总结
The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.
详细描述
In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •elective shoulder surgery in the beach chair position
排除标准
- •less than 18 years of age
- •preoperative score of 23 or less on the pre-operative Mini Mental State Exam
- •traumatic brain injury
- •transient ischemic attack
- •cerebrovascular incident
- •any apparent clinical neurologic dysfunction
- •carotid artery stenosis
- •known vascular malformation in head
- •inability to have blood pressure measured in the opposite extremity
- •malignant hyperthermia
研究组 & 干预措施
NIRS Monitored Not Treated
Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS)
干预措施: NIRS monitored not treated (Device)
NIRS Monitored and Treated
Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS)
干预措施: NIRS (Device)
结局指标
主要结局
Percentage of Participants With 20+% Cerebral Desaturation Events
时间窗: one day
Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position
次要结局
- Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value(baseline and up to two weeks)
研究者
George K Bal
Associate Professor
West Virginia University