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NCT04948385
Driving Performance After Deep Sedation for Outpatient Endoscopy
Phase 4 trial testing Propofol in Driving Impaired in 60 participants. Completed in 6 May 2019.
6 May 2019
Quick facts
| Lead sponsor | University of Liege |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 6 February 2019 |
| Primary completion | 6 May 2019 |
| Estimated completion | 6 May 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Propofol (Propofol) — full drug profile →
- No sedation — full drug profile →
Conditions studied
- Driving Impaired — all drugs for Driving Impaired →
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.
Verify or expand the search:
- PubMed search for NCT04948385
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other recruiting trials for Driving Impaired
Currently open trials in the same condition.
- NCT06872593 — Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal · NA · recruiting
Other University of Liege trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04948385 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Liege
- Last refreshed: 2 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04948385.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing