Driving Performance After Deep Sedation for Outpatient Endoscopy

Sponsor

University of Liege (Other)

Overall Status

Completed

CT.gov ID

NCT04948385

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

20.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Driving Impaired	Drug: Propofol Procedure: No sedation	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 ?

Actual Study Start Date :

Feb 6, 2019

Actual Primary Completion Date :

May 6, 2019

Actual Study Completion Date :

May 6, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire de Liege	Liège		Belgium	4000

Sponsors and Collaborators

University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Claude Hallet, Principal investigator, University of Liege

ClinicalTrials.gov Identifier:

NCT04948385

Other Study ID Numbers:

B7007201938885

First Posted:

Jul 2, 2021

Last Update Posted:

Jul 2, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Jul 2, 2021