Driving Performance After Deep Sedation for Outpatient Endoscopy

NCT04948385 | Completed Phase 4

• 1 other identifier: B7007201938885
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Driving Impaired

Outcome Measures

Primary Outcomes (14)

• 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 (4)

• Karolinska Sleepiness Scale (KSS)

  Within 30 minutes before driving test with simulator

• Karolinska Sleepiness Scale (KSS)

  Within 10 minutes after driving test with simulator

• Beck II Depression inventory score (BDI-II)

  Within 30 minutes before driving test with simulator

• STOP-Bang questionnaire (Snoring, Tired, Observed, Pressure, Body Mass index > 35, Age, Neck size, Gender)

  Within 30 minutes before driving test with simulator

Study Arms (2)

Patients

ACTIVE COMPARATOR

Deep sedation for digestive endoscopy.

Drug: Propofol

Escorts

OTHER

Accompanying persons are the adults who accompany the patients home. They do not receive any medication or intervention.

Procedure: No sedation

Interventions

Propofol DRUG

deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol

Patients

No sedation PROCEDURE

No sedation

Escorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of a driver license

You may not qualify if:

• Unavailabilty of the escort for the duration of the examination
• No driving for the past 5 years
• Refusal of participation

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Centre hospitalier universitaire de Liege

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: July 2, 2021
• Study Start: February 6, 2019
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)