跳至主要内容
临床试验/NCT00176098
NCT00176098Unknown1 期

Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery

Heidelberg University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
1 期
入组人数
70
试验地点
2
主要终点
Reduction of perioperative stress

研究概览

简要总结

Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.

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

入排标准

年龄范围
10 Years 至 95 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Uncorrected hearing disability
  • Pharmacological beta-blockade

结局指标

主要结局

Reduction of perioperative stress

Improvement of patient comfort and safety

次要结局

  • Correlation of hypnotic depth with bispectral index (BIS)

研究者

申办方类型
Other

研究点 (2)

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