Anaesthetist-Controlled Compared with Effect-site Patient-maintained Target-controlled Sedation (ACCEPTS)

Not Applicable

Completed

• Conditions: Hip or knee replacements; Surgery; Other joint disorders

• Registration Number: ISRCTN29129799
• Lead Sponsor: ottingham University Hospitals NHS Trust

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-12
• Study Completion: 2020-02-01
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of propofol consumption. The total propofol consumption in milligrams received by the patient using the PMPSD will be recorded every second throughout the sedation period on a Dell 5414 Latitude Rugged laptop. At the end of surgery, consumption will be expressed as the total number of milligrams of propofol delivered, adjusted for body weight and expressed as a rate across the duration of the sedation period (unit: milligrams per kilogram per hour). The sedation period is defined from the time of commencement of sedation by the supervising clinical anaesthetist up until the time when surgery ends, being when clips are applied by the operating surgeon to the surgical incision.