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临床试验/ISRCTN29129799
ISRCTN29129799已完成未知

A parallel-group, randomised comparison trial of anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower limb arthroplasty performed under spinal anaesthesia

ottingham University Hospitals NHS Trust0 个研究点目标入组 80 人开始时间: 2018年6月12日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
80

研究概览

简要总结

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30760311 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34852928/ (added 03/12/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Listed to undergo elective primary hip or knee arthroplasty under spinal anaesthesia
  • 2. Expressing a pre-operative preference for sedation during surgery
  • 3. Able to communicate in written and spoken English
  • 4. Capable of giving informed consent
  • 5. Age >18 years

排除标准

  • 1. Allergy to propofol
  • 2. Medical contraindication to spinal anaesthesia (for example local infection at injection site, patient refusal, allergy to local anaesthetic agent, untreated systemic infection, untreated coagulopathy)
  • 3. Expressing pre-operative preference for surgery to be performed awake or under general anaesthesia.
  • 4. Inability to use handheld trigger system of the PMPSD
  • 5. Pregnant or breastfeeding

研究者

发起方
ottingham University Hospitals NHS Trust

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