Hip or knee replacements Surgery Other joint disorders
Conditions
Interventions
Enrolled participants will be randomised by block randomisation technique to one of two groups: Group: Patient-maintained propofol sedation (PMPS) and Group: Anaesthetist-controlled propofol sedation
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The depth of sedation of patients will be assessed by a study investigator at five-minute intervals during the sedation period and in the post-sedation PACU phase. The Modified Observer Assessment of Alertness and Sedation (mOAA/S) Scale will be used to determine depth of sedation. Over-sedated will be defined as mOAA/S score 1 or 0 2. Peri-operative anxiety assessed (i) pre-operatively in theatres admissions lounge (THAL) using a questionnaire in which the patient is asked to provide written check-box answers to 27 questions scored on Likert scales, and (ii) post-operative in PACU using a questionnaire administered by a study investigator once the patient is fully awake and orientated, the patient is asked to provide verbal answers to 6 questions scored on a Likert scale. After discharge from hospital, anxiety levels will be baselined using responses obtained by telephone interview administered by a study investigator: patient to provide verbal answers to 6 questions scored on a Likert scale 3. Patient satisfaction with their sedation regime assessed (i) pre-operatively in THAL where the patient is asked to provide written check-box answers to 4 yes/no/unknown baseline questions, (ii) post-operative in PACU and administered by a study investigator once the patient is fully awake and orientated the patient is asked to provide verbal answers to 22 questions scored on a Likert scale (11 of which constitute the ‘Iowa Satisfaction with Sedation Scale’) and if assigned to the PMPS arm of the trial a further 9 questions scored on a Likert scale plus 1 open-ended question, and (iii) after discharge from hospital and administered by a study investigator question numbers depend on trial arm assignment: if to PMPS, 4 questions scored on a Likert scale plus 6 open-ended questions; if to ACPS, 4 questions scored on a Likert scale 4. Patient recovery from surgery and anaesthesia assessed using the QoR15 questionnaire, consisting | — |
Countries
England, United Kingdom
Outcome results
None listed