ACCEPTS Trial (Clinical Investigation Plan version 1.3)
Research type
Research Study
Full title
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. Short Title: Anaesthetist-Controlled Compared with Effect-site Patient-maintained Target-controlled Sedation (ACCEPTS)
IRAS ID
231688
Contact name
Nigel Bedforth
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust Research and Innovation Department
ISRCTN Number
29129799
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Over 200,000 hip or knee replacements are performed annually in the UK. The majority are performed under spinal anaesthesia, which makes the operative site numb, but does not affect conscious level. Sedation is commonly given to patients during surgery because many people do not like to be fully awake during their operation.
The infusion of propofol, under the direction of an anaesthetist, is a popular choice for operative sedation. Anaesthetists however, have been shown to be inaccurate judges of patients anxiety. This could result in either insufficient or excessive dosing of propofol in relation to the actual needs of individual patients. One possibility for overcoming this is allowing patients to exert control over the amount of sedation they receive.
This study will directly compare patient-maintained propofol sedation with anaesthetist-controlled propofol sedation in patients undergoing hip or knee replacements. We want to know if putting patients in control of their sedation results in less overall drug being used compared to when anaesthetists control the infusion, and whether patients like being in control of their own sedation.
REC name
Wales REC 6
REC reference
18/WA/0190
Date of REC Opinion
28 Jun 2018
REC opinion
Further Information Favourable Opinion