Driving Performance After Deep Sedation for Outpatient Endoscopy

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 ?

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.

Study Overview

• Status: Completed
• Conditions: Driving Impaired
• Intervention / Treatment: Drug: Propofol; Procedure: No sedation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): May 6, 2019
• Study Completion (Actual): May 6, 2019

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: B7007201938885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No