The Effect of Depth of Anesthesia on Implicit Memory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To test the presence of implicit memory under two different planes of surgical general anesthesia in patients undergoing urologic (transurethral) or orthopedic (internal and external fixation) procedures
研究概览
简要总结
Purpose of this study is to see if different levels of anesthesia have an effect on hearing spoken words without awareness of having heard them or anxiety after surgery.
详细描述
Amnesia (lack of recall) is one of the most important goals of general anesthesia. Inadvertent free recall during a major surgical procedure is not only inhumane, but also predisposes the patient to morbidity such as post-traumatic stress disorder. Therefore, it is standard practice among anesthesiologists to inquire about free (explicit) recall during a post-anesthetic visit.
Free recall requires a functional long term memory. Historically, lack of free recall during general anesthesia has been regarded as complete absence of long term memory activity. However, recent evidence suggests that the relationship between general anesthesia and memory is more complex than previously thought.
Objectives of the proposed are twofold: (1) to test the presence of implicit memory under two different planes of surgical general anesthesia in elderly males (55-90 years old) during a uniform surgical procedure (urologic procedures via transurethral approach) (2) to compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.
The study is divided into three phases: pre-operative, operative, and post-operative.
Pre-operative phase will consist of a cognitive function test (mini-mental state exam). This will be administered at the urology or pre-operative anesthesia clinic visit, after obtaining the informed consent of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons signing informed consent
- •Elective general surgery for orthopedics (external or internal fixation) or urologic (transurethral)
- •Native English speaking
排除标准
- •Hearing impaired
- •History of cognitive dysfunction
- •Subjects requiring post-operative sedation for any indication
研究组 & 干预措施
Bispectral Index (BIS) 40
Target BIS 40
干预措施: BIS 40 (Combination Product)
Bispectral Index (BIS) 40
Target BIS 40
干预措施: BIS 60 (Combination Product)
Bispectral Index (BIS) 60
Target BIS 60
干预措施: BIS 40 (Combination Product)
Bispectral Index (BIS) 60
Target BIS 60
干预措施: BIS 60 (Combination Product)
结局指标
主要结局
To test the presence of implicit memory under two different planes of surgical general anesthesia in patients undergoing urologic (transurethral) or orthopedic (internal and external fixation) procedures
时间窗: 3 years
次要结局
- To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.(3)
