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NCT04948385

Driving Performance After Deep Sedation for Outpatient Endoscopy

Completed Phase 4 Last updated 2 July 2021
What this trial tests

Phase 4 trial testing Propofol in Driving Impaired in 60 participants. Completed in 6 May 2019.

Timeline
6 February 2019
Primary endpoint
6 May 2019
6 May 2019

Quick facts

Lead sponsorUniversity of Liege
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment60
Start date6 February 2019
Primary completion6 May 2019
Estimated completion6 May 2019
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

University of Liege

Who can join

18 and older, any sex, with Driving Impaired. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Propofol

Trials testing the same drug.

Other recruiting trials for Driving Impaired

Currently open trials in the same condition.

Other University of Liege trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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