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临床试验/NCT00584324
NCT00584324已完成不适用

The Effect of Depth of Anesthesia on Implicit Memory

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2006年3月最近更新:
适应症
干预措施

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

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

Experimental

Target BIS 40

干预措施: BIS 40 (Combination Product)

Bispectral Index (BIS) 40

Experimental

Target BIS 40

干预措施: BIS 60 (Combination Product)

Bispectral Index (BIS) 60

Experimental

Target BIS 60

干预措施: BIS 40 (Combination Product)

Bispectral Index (BIS) 60

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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