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Completed

NCT Number: NCT04948385

Driving Performance After Deep Sedation for Outpatient Endoscopy

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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Key information

Conditions

Driving Impaired

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre hospitalier universitaire de Liege

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

No sedation

Procedure

No sedation

Primary outcomes

  1. Travel time

    Time frame: until the end of the driving test, an average of 1 hour.

  2. Number of collisions

    Time frame: until the end of the driving test, an average of 1 hour.

  3. Number of collisions with a pedestrian

    Time frame: until the end of the driving test, an average of 1 hour.

  4. Number of times over the speed limit

    Time frame: until the end of the driving test, an average of 1 hour.

  5. Percentage of speeding time

    Time frame: until the end of the driving test, an average of 1 hour.

  6. Percentage of speeding distance

    Time frame: until the end of the driving test, an average of 1 hour.

  7. Number of speeding ticket

    Time frame: until the end of the driving test, an average of 1 hour.

  8. Number of crossings of the median line

    Time frame: until the end of the driving test, an average of 1 hour.

  9. Number of passages on the shoulder

    Time frame: until the end of the driving test, an average of 1 hour.

  10. Percentage of time out of traffic lane

    Time frame: until the end of the driving test, an average of 1 hour.

  11. Percentage of distance out of traffic lane

    Time frame: until the end of the driving test, an average of 1 hour.

  12. Number of broken stops

    Time frame: until the end of the driving test, an average of 1 hour.

  13. Number of stops at traffic lights

    Time frame: until the end of the driving test, an average of 1 hour.

  14. Number of traffic light ticket

    Time frame: until the end of the driving test, an average of 1 hour.

Secondary outcomes

  1. Karolinska Sleepiness Scale (KSS)

    Time frame: Within 30 minutes before driving test with simulator

    9-points scale : 1 (extremely alert) to 9 (very sleepy)

  2. Karolinska Sleepiness Scale (KSS)

    Time frame: Within 10 minutes after driving test with simulator

    9-points scale : 1 (extremely alert) to 9 (very sleepy)

  3. Beck II Depression inventory score (BDI-II)

    Time frame: Within 30 minutes before driving test with simulator

    21 items - 0 to 3 points by item - 0 (minimal) to 63 (severe depression)

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

    Time frame: Within 30 minutes before driving test with simulator

    0 to 8 points (0 = low risk to 8 = high risk of sleep apnea)

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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 ?

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2021
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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