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临床试验/NCT01228162
NCT01228162已完成4 期

Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation

Klinikum Hildesheim GmbH1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
degree of muscle trauma

研究概览

简要总结

The researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).

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
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient agreement
  • indication for total hip replacement
  • age 55 - 80 years
  • weight 65 - 95 kg
  • first intervention
  • ASA classification I - III
  • general and spinal anaesthesia possible in this patient

排除标准

  • a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea

结局指标

主要结局

degree of muscle trauma

时间窗: 24 hours

serum CK and CRP levels are measured

次要结局

  • consumption of analgetics(3 days)

研究者

发起方
Klinikum Hildesheim GmbH
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jens Ebnet

MD

Klinikum Hildesheim GmbH

研究点 (1)

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