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临床试验/NCT01491009
NCT01491009已完成不适用

Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies

Gazi University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2006年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Degree of sedative efficiency

研究概览

简要总结

The aim of the study was to compare the effects of remifentanil-dexmedetomidine and remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care (MAC) patients undergoing cystoscopy.

详细描述

Forty patients undergoing cystoscopy receiving remifentanil infusion of 0.05 microgram per kg-1 min-1 were randomized into two groups: Either dexmedetomidine 1 microgram per kg -1 (GroupD) or midazolam 0.2 mg kg-1h-1 (GroupM) were administered intravenously for the first 10 minutes. Subsequently anesthesia was maintained by using the bispectral index(BIS) as a continuous infusion of dexmedetomidine 0.2-0.7 microgram per kg-1h-1 or midazolam 0.05-0.15 mgkg-1h-1. Heart rate, mean arterial pressure, MMSE, sedation and the patient's and surgeon's satisfaction were determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with indication of cystoscopy must be able to have sedation

排除标准

  • hypersensitivity to drugs used
  • morbid obesity
  • coronary disease
  • diabetes mellitus and other endocrinologic diseases
  • pregnancy
  • psychomotor diseases

结局指标

主要结局

Degree of sedative efficiency

时间窗: During cystoscopy procedure

Bispectral Index (BIS) was used.

Degree of cognitive functions

时间窗: Postoperative 60 minutes

mini-mental state examination(MMSE) test was used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Hande Arpacı

Dr. at Department of Anaesthesiology and Reanimation

Gazi University

研究点 (2)

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