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Clinical Trials/ISRCTN29129799
ISRCTN29129799
Completed
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 sites80 target enrollmentJune 12, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Hip or knee replacements
Sponsor
ottingham University Hospitals NHS Trust
Enrollment
80
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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)

Registry
who.int
Start Date
June 12, 2018
End Date
February 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ottingham University Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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