TerminatedNot Applicable

Driving Skills Recovery Following Procedural Sedation for Gastrointestinal Endoscopy

Stopped: Lack of resources and Covid-19

United States68 participantsStarted 2019-03-05

Plain-language summary

This is a prospective cohort study that will analyze psychomotoric recovery using a commercially available driving simulator following sedation for endoscopic procedures in subjects undergoing elective outpatient endoscopic procedures. Patients receiving both propofol based sedation and well as those receiving a combination of fentanyl and midazolam will be studied. Baseline data will be obtained after training on the simulator. Following the procedure and after meeting standard discharge criteria, the subjects will undergo the same driving simulation to ascertain psychomotoric recovery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English speaking subjects ≥18 years * Currently hold a valid driver's license * Able to give informed consent * Undergoing either anesthesiologist directed propofol sedation targeting deep sedation (Group1) or a combination of an opioid and benzodiazepine targeting moderate sedation (Group 2) for elective outpatient procedures Exclusion Criteria: * Inpatients * Subjects patients with altered mental status * Subjects with legal blindness * Physical limitations that would not make them candidates to be tested in the driving simulator * American Society of Anesthesiologists physical classification score ≥ 4 * Urgent procedures * Systolic hypotension defined as a systolic blood pressure ≤ 90 mmHg * Subjects in whom English is not a primary language.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Median number of summated deviations

Timeframe: From end of procedure until discharge, typically less than 4 hours

Center Lane Errors

Timeframe: From end of procedure until discharge, typically less than 4 hours

Median minimum distance to vehicle (feet).

Timeframe: From end of procedure until discharge, typically less than 4 hours

Mean brake pedal reaction time (seconds)

Timeframe: From end of procedure until discharge, typically less than 4 hours

Trial details

NCT IDNCT04350424

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-12

View on ClinicalTrials.gov More Anesthesia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Median number of summated deviations

Timeframe: From end of procedure until discharge, typically less than 4 hours

Center Lane Errors

Timeframe: From end of procedure until discharge, typically less than 4 hours

Median minimum distance to vehicle (feet).

Timeframe: From end of procedure until discharge, typically less than 4 hours

Mean brake pedal reaction time (seconds)

Timeframe: From end of procedure until discharge, typically less than 4 hours