Driving Performance After Deep Sedation for Outpatient Endoscopy

University of Liege

Status and phase: Completed; Phase 4

Conditions: Driving Impaired

Treatments: Procedure: No sedation; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04948385

B7007201938885

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients

Active Comparator group

Description:

Deep sedation for digestive endoscopy.

Treatment:

Drug: Propofol

Escorts

Other group

Description:

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

Treatment:

Procedure: No sedation