Driving Performance After Deep Sedation for Outpatient Endoscopy

NCT04948385 — Phase 4, Completed, 60 participants, University of Liege

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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 ?

Registry	NCT04948385
Status	Completed
Phase	Phase 4
Study type	Interventional; non randomized, parallel, masking: none, prevention
Enrollment	60 (Actual)
Sponsor	University of Liege (Other)
Conditions	Driving Impaired
Interventions	Propofol, No sedation (Drug, procedure)
Dates	start 2019-02-06, primary completion 2019-05-06, completion 2019-05-06, first posted 2021-07-02, last updated 2021-07-02
Locations	1 site in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients	Active comparator	Drug: Propofol	Deep sedation for digestive endoscopy.
Escorts	Other	Procedure: No sedation	Accompanying persons are the adults who accompany the patients home. They do not receive any medication or intervention.

Propofol (Drug): deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol
No sedation (Procedure): No sedation

+Outcome measures

Primary outcomes

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.]
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.]
Number of traffic light ticket [until the end of the driving test, an average of 1 hour.]

Secondary outcomes

Karolinska Sleepiness Scale (KSS) [Within 30 minutes before driving test with simulator]: 9-points scale : 1 (extremely alert) to 9 (very sleepy)
Karolinska Sleepiness Scale (KSS) [Within 10 minutes after driving test with simulator]: 9-points scale : 1 (extremely alert) to 9 (very sleepy)
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)

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Centre hospitalier universitaire de Liege	Liège	Belgium