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临床试验/NCT03355352
NCT03355352Unknown不适用

Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump) After Urogenital Intervention at the Clinical Daily Routine

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
analgesic quality

研究概览

简要总结

The observational study will check if there is a difference in the postoperative care of patients with urogenital intervention while using the standard PCA-syringe pump or using the Zalviso sufentanyl sublingual analgetic system.

The study will exactly examine, using questionaire for the patient, the medical stuff (nurses and anesthesiologist) the difference in the analgetic quality, the difference of the patients' mobility while being treated with one of the analgetic system and if there is a difference in the cost-efficiency.

We want to examine 50 Patients in each group. The studies should be finished in about one year.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients after urological interventions with no indication of an periduralanästesia
  • Patients compliant for a PCA system, and complied with the analysis of their data

排除标准

  • F03 dementia
  • F10.2 dependence syndrome alcohol
  • F11.2 dependence syndrome opioids
  • F12.2 dependence syndrome cannabinoids
  • F13.2 dependence syndrome sedatives and hypnotics
  • F14.2 dependence syndrome cocaine
  • F15.2 dependence syndrome coffin
  • F.16.2 dependence syndrome hallucinogens
  • F22 schizophrenia
  • F41.1 generalized anxiety disorder

研究组 & 干预措施

Patients treated with Zalviso

干预措施: Sufentanil (Drug)

结局指标

主要结局

analgesic quality

时间窗: 1 year

Recording of the analgesic quality measured by the request of more analgesic postoperative while being treated with the conventional PCA or the Zalviso system.

mobility

时间窗: 1 year

Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.

次要结局

  • medical cost efficiency(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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