Clinical trial NCT04948385: Driving Performance After Deep Sedation for Outpatient Endoscopy
Official title: Can Patients Who Have Undergone a Digestive Endoscopy Under Deep Sedation Drive Their Vehicle as Soon as a Post-Anesthetic Discharge Scoring System (PADDS) Equal to 9 is Obtained ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Driving Impaired
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Travel time
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of collisions
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of collisions with a pedestrian
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of times over the speed limit
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Percentage of speeding time
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Percentage of speeding distance
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of speeding ticket
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of crossings of the median line
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of passages on the shoulder
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Percentage of time out of traffic lane
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Percentage of distance out of traffic lane
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of broken stops
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of stops at traffic lights
timeFrame: until the end of the driving test, an average of 1 hour.
measure: Number of traffic light ticket
timeFrame: until the end of the driving test, an average of 1 hour.
Secondary outcomes:
measure: Karolinska Sleepiness Scale (KSS)
timeFrame: Within 30 minutes before driving test with simulator
measure: Karolinska Sleepiness Scale (KSS)
timeFrame: Within 10 minutes after driving test with simulator
measure: Beck II Depression inventory score (BDI-II)
timeFrame: Within 30 minutes before driving test with simulator
measure: STOP-Bang questionnaire (Snoring, Tired, Observed, Pressure, Body Mass index > 35, Age, Neck size, Gender)
timeFrame: Within 30 minutes before driving test with simulator
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre hospitalier universitaire de Liege
Study officials:
References: