Driving Performance After Deep Sedation for Outpatient Endoscopy

Driving Impaired Clinical Trial

Official 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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948385
• Other study ID #: B7007201938885
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: June 2021
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Driving Impaired

Intervention

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

Procedure:
• No sedation
No sedation

Locations

Country	Name	City	State
Belgium	Centre hospitalier universitaire de Liege	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Travel time		until the end of the driving test, an average of 1 hour.
Primary	Number of collisions		until the end of the driving test, an average of 1 hour.
Primary	Number of collisions with a pedestrian		until the end of the driving test, an average of 1 hour.
Primary	Number of times over the speed limit		until the end of the driving test, an average of 1 hour.
Primary	Percentage of speeding time		until the end of the driving test, an average of 1 hour.
Primary	Percentage of speeding distance		until the end of the driving test, an average of 1 hour.
Primary	Number of speeding ticket		until the end of the driving test, an average of 1 hour.
Primary	Number of crossings of the median line		until the end of the driving test, an average of 1 hour.
Primary	Number of passages on the shoulder		until the end of the driving test, an average of 1 hour.
Primary	Percentage of time out of traffic lane		until the end of the driving test, an average of 1 hour.
Primary	Percentage of distance out of traffic lane		until the end of the driving test, an average of 1 hour.
Primary	Number of broken stops		until the end of the driving test, an average of 1 hour.
Primary	Number of stops at traffic lights		until the end of the driving test, an average of 1 hour.
Primary	Number of traffic light ticket		until the end of the driving test, an average of 1 hour.
Secondary	Karolinska Sleepiness Scale (KSS)	9-points scale : 1 (extremely alert) to 9 (very sleepy)	Within 30 minutes before driving test with simulator
Secondary	Karolinska Sleepiness Scale (KSS)	9-points scale : 1 (extremely alert) to 9 (very sleepy)	Within 10 minutes after driving test with simulator
Secondary	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
Secondary	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