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)
Investigators
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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