Driving Performance After Deep Sedation for Outpatient Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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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 ?

Conditions
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Driving Impaired

Intervention / Treatment
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* Drug: Propofol
* Procedure: No sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients<br>Deep sedation for digestive endoscopy. | Drug: Propofol<br>* deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol<br>|
| Other: Escorts<br>Accompanying persons are the adults who accompany the patients home. They do not receive any medication or intervention. | Procedure: No sedation<br>* No sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karolinska Sleepiness Scale (KSS) | 9-points scale : 1 (extremely alert) to 9 (very sleepy) | Within 30 minutes before driving test with simulator | 
| Karolinska Sleepiness Scale (KSS) | 9-points scale : 1 (extremely alert) to 9 (very sleepy) | Within 10 minutes after driving test with simulator | 
| Beck II Depression inventory score (BDI-II) | 21 items - 0 to 3 points by item - 0 (minimal) to 63 (severe depression) | Within 30 minutes before driving test with simulator | 
| STOP-Bang questionnaire (Snoring, Tired, Observed, Pressure, Body Mass index > 35, Age, Neck size, Gender) | 0 to 8 points (0 = low risk to 8 = high risk of sleep apnea) | Within 30 minutes before driving test with simulator |