Driving Impaired
Conditions
Brief summary
Many drugs used during anesthesia can reduce alertness and therefore present potential risks when driving a vehicle (risk of accident). Some scientific societies recommend not driving for 12 to 24 hours after sedation or general anesthesia. However, there are conflicting data in the literature showing that general anesthesia in healthy volunteers does not impair driving ability as early as 2 hours after the end of anesthesia. This need not to drive requires the outpatient to have an escort. Unfortunately, some patients find it difficult to benefit from an adult escort, which can lead to last minute cancellations, absences or the need for a classic overnight hospital stay. The main objective of the study is to compare with a simulator the driving performances of patients who have benefited from deep sedation for an outpatient endoscopic digestive procedure when they have met the discharge criteria to the performances of their escorts in order to determine if the conditions are as safe to let them drive home.
Interventions
DRUGPropofol
deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol
PROCEDURENo sedation
No sedation
Sponsors
University of Liege
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Presence of a driver license
Exclusion criteria
* Unavailabilty of the escort for the duration of the examination * No driving for the past 5 years * Refusal of participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of traffic light ticket | until the end of the driving test, an average of 1 hour. |
| Percentage of distance out of traffic lane | until the end of the driving test, an average of 1 hour. |
| Number of broken stops | until the end of the driving test, an average of 1 hour. |
| Number of stops at traffic lights | until the end of the driving test, an average of 1 hour. |
| Travel time | until the end of the driving test, an average of 1 hour. |
| Number of collisions | until the end of the driving test, an average of 1 hour. |
| Number of collisions with a pedestrian | until the end of the driving test, an average of 1 hour. |
| Number of times over the speed limit | until the end of the driving test, an average of 1 hour. |
| Percentage of speeding time | until the end of the driving test, an average of 1 hour. |
| Percentage of speeding distance | until the end of the driving test, an average of 1 hour. |
| Number of speeding ticket | until the end of the driving test, an average of 1 hour. |
| Number of crossings of the median line | until the end of the driving test, an average of 1 hour. |
| Number of passages on the shoulder | until the end of the driving test, an average of 1 hour. |
| Percentage of time out of traffic lane | until the end of the driving test, an average of 1 hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck II Depression inventory score (BDI-II) | Within 30 minutes before driving test with simulator | 21 items - 0 to 3 points by item - 0 (minimal) to 63 (severe depression) |
| STOP-Bang questionnaire (Snoring, Tired, Observed, Pressure, Body Mass index > 35, Age, Neck size, Gender) | Within 30 minutes before driving test with simulator | 0 to 8 points (0 = low risk to 8 = high risk of sleep apnea) |
| Karolinska Sleepiness Scale (KSS) | Within 30 minutes before driving test with simulator | 9-points scale : 1 (extremely alert) to 9 (very sleepy) |
Countries
Belgium
Outcome results
None listed