None listed
Conditions
Brief summary
Abstinence from driving a motor vehicle is recommended for 24 hours following procedural sedation. Despite this, as many as 1 in 10 people drive in the first 24 hours after day surgery, and nearly the same amount report driving home immediately after they have been discharged form hospital. Drivers are often guided by their treating physicians to abstain from driving until ‘physical and mental recovery is compatible with safe driving’, however, there is no clear standard on what constitutes compatibility with safe driving, nor what benchmark is considered acceptable in terms of physical and mental recovery. This project aims to gather vital information about the performance-based effects of sedating-type medications on driving performance to provide treatment-relevant data to inform postoperative driving restrictions and inform patient discharge procedures.
Interventions
Over a two week period, participants will be observed pre-operatively (V1) and post-operatively (V2 and V3) as they undergo scheduled elective day surgery procedures.
Specifically, performance assessments will take place in three stages;
T1: No greater than 1 week pre-surgery admission (in-lab)
T2: up to 24 hours post-hospital discharge (T2a) and at day/s 3 (T2b) and 7 (T2c) postoperatively (at-home)
T3: at 8-days postoperatively (in-lab)
The CANTAB System will be used to assess the cognitiv
Over a two week period, participants will be observed pre-operatively (V1) and post-operatively (V2 and V3) as they undergo scheduled elective day surgery procedures. Specifically, performance assessments will take place in three stages; T1: No greater than 1 week pre-surgery admission (in-lab) T2: up to 24 hours post-hospital discharge (T2a) and at day/s 3 (T2b) and 7 (T2c) postoperatively (at-home) T3: at 8-days postoperatively (in-lab) The CANTAB System will be used to assess the cognitive effects at V1 (in-lab), V2a, V2b, V2c (at-home) and V3 (in-lab). Seven tasks will be used in this study to assess cognitive, executive and memory function, specifically: 1. Reaction time (Processing and Psychomotor Speed) 2. Paired Associates Learning 3. Spatial Working Memory (Working Memory & strategy) 4. Attention Switching Task (Attention Switching) – Renamed Multitasking Task (MTT) 5. One Touch Stocking of Cambridge (Planning) 6. Rapid Visual Information Processing (Sustained Attention) 7. Visual Analogue Scale (VAS) Driving performance will be assessed using the Forum 8 driving simulator at V1 and V3, for a 40 minute duration. The simulator consists of a car unit with adjustable car seats and a dashboard and includes a steering wheel, turn sign indicators, gear lever, brake and accelerator pedals for vehicle control. The system generates realistic roadway scenery which is presented on three integrated TV screens 1.90 meters in front of the centre of the steering wheel. The speed and gear number are displayed on the dashboard and screen. Auditory feedback is provided by speakers and included the sound of the engine, braking, speeding in curves, and driving off-road. Real-life driving performance will be assessed from V1-V3 using the in-situ IndigoGPS system. The system combines GLONASS GPS technology with in-vehicle diagnostics to provide live tracking and driver activity reporting.
Sponsors
Swinburne University of Technology
Eligibility
Sex/Gender
All
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Male or female, aged 21 to 55 years; Undergoing elective day surgery procedures from July 2019 - March 2020 Willing and able to provide written informed consent; Understands and is willing and able to comply with all study procedures; Fluent in written and spoken English; Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence; Willing to abstain from the following prior to their scheduled in-lab visits (V1 and V3): No caffeine-containing products within 12 hours prior to testing; No alcohol within 24 hours prior to testing No illicit substance use for one week prior to, and for the duration of the trial.
Exclusion criteria
Unable to understand or comply with testing procedures; Inability to speak or read English; History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders; Pregnant, potentially pregnant or lactating; Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol; Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit; Have previously participated in this study.
Outcome results
None listed