Driving ImpairedPhase 4NCT04948385
Driving Performance After Deep Sedation for Outpatient Endoscopy
A Phase 4 study testing Propofol and No sedation in people with Driving Impaired, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Driving Impaired
- What is being tested?
- Propofol and No sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Feb 2019to 6 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of a driver license
Who cannot join
- Unavailabilty of the escort for the duration of the examination
- No driving for the past 5 years
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
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 ?
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.
- Conditions
- Driving Impaired
- Being tested
- Propofol, No sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol
No sedationProcedure or surgery
No sedation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Deep sedation for digestive endoscopy. Receives: Drug: Propofol |
| Escorts | Other | Accompanying persons are the adults who accompany the patients home. They do not receive any medication or intervention. Receives: Procedure: No sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Travel time
Measured: until the end of the driving test, an average of 1 hour.
Number of collisions
Measured: until the end of the driving test, an average of 1 hour.
Number of collisions with a pedestrian
Measured: until the end of the driving test, an average of 1 hour.
Number of times over the speed limit
Measured: until the end of the driving test, an average of 1 hour.
Percentage of speeding time
Measured: until the end of the driving test, an average of 1 hour.
Percentage of speeding distance
Measured: until the end of the driving test, an average of 1 hour.
Number of speeding ticket
Measured: until the end of the driving test, an average of 1 hour.
Number of crossings of the median line
Measured: until the end of the driving test, an average of 1 hour.
Number of passages on the shoulder
Measured: until the end of the driving test, an average of 1 hour.
Percentage of time out of traffic lane
Measured: until the end of the driving test, an average of 1 hour.
Percentage of distance out of traffic lane
Measured: until the end of the driving test, an average of 1 hour.
Number of broken stops
Measured: until the end of the driving test, an average of 1 hour.
Number of stops at traffic lights
Measured: until the end of the driving test, an average of 1 hour.
Number of traffic light ticket
Measured: until the end of the driving test, an average of 1 hour.
Secondary outcomes (4)
Karolinska Sleepiness Scale (KSS)
9-points scale : 1 (extremely alert) to 9 (very sleepy)
Measured: Within 30 minutes before driving test with simulator
Karolinska Sleepiness Scale (KSS)
9-points scale : 1 (extremely alert) to 9 (very sleepy)
Measured: Within 10 minutes after driving test with simulator
Beck II Depression inventory score (BDI-II)
21 items - 0 to 3 points by item - 0 (minimal) to 63 (severe depression)
Measured: Within 30 minutes before driving test with simulator
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)
Measured: Within 30 minutes before driving test with simulator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start6 Feb 2019
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Driving ImpairedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Hallet, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948385
- Sponsor's protocol ID
- B7007201938885
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ?
- ClinicalTrials.gov ID
- NCT04948385
- Acronym / sponsor ID
- B7007201938885
- Conditions
- Driving Impaired
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Drug: PropofolDeep sedation for digestive endoscopy. |
| Escorts | Other | Procedure: No sedationAccompanying persons are the adults who accompany the patients home. They do not receive any medication or intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of a driver license
Key exclusion criteria (3 listed)
- Unavailabilty of the escort for the duration of the examination
- No driving for the past 5 years
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofoldeep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol | Drug | Patients |
| No sedationNo sedation | Procedure or surgery | Escorts |
Primary outcome
Travel time
Time frame: until the end of the driving test, an average of 1 hour.
Number of collisions
Time frame: until the end of the driving test, an average of 1 hour.
Number of collisions with a pedestrian
Time frame: until the end of the driving test, an average of 1 hour.
Number of times over the speed limit
Time frame: until the end of the driving test, an average of 1 hour.
Percentage of speeding time
Time frame: until the end of the driving test, an average of 1 hour.
Percentage of speeding distance
Time frame: until the end of the driving test, an average of 1 hour.
Number of speeding ticket
Time frame: until the end of the driving test, an average of 1 hour.
Number of crossings of the median line
Time frame: until the end of the driving test, an average of 1 hour.
Number of passages on the shoulder
Time frame: until the end of the driving test, an average of 1 hour.
Percentage of time out of traffic lane
Time frame: until the end of the driving test, an average of 1 hour.
Percentage of distance out of traffic lane
Time frame: until the end of the driving test, an average of 1 hour.
Number of broken stops
Time frame: until the end of the driving test, an average of 1 hour.
Number of stops at traffic lights
Time frame: until the end of the driving test, an average of 1 hour.
Number of traffic light ticket
Time frame: until the end of the driving test, an average of 1 hour.
4 secondary outcomes
Karolinska Sleepiness Scale (KSS)
Time frame: Within 30 minutes before driving test with simulator
Karolinska Sleepiness Scale (KSS)
Time frame: Within 10 minutes after driving test with simulator
Beck II Depression inventory score (BDI-II)
Time frame: Within 30 minutes before driving test with simulator
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and No sedation in people with Driving Impaired, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Travel time (time frame: until the end of the driving test, an average of 1 hour.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.