Status:
TERMINATED
Driving Skills Recovery Following Procedural Sedation for Gastrointestinal Endoscopy
Lead Sponsor:
The Cleveland Clinic
Conditions:
Anesthesia
Psychomotor Status
Eligibility:
All Genders
18+ years
Brief 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 electiv...
Detailed Description
Procedural sedation for ambulatory endoscopy procedures is delivered millions of times per year in the United States. Current standard of care necessitates the presence of a responsible adult to take ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 12 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04350424
Start Date
March 5 2019
End Date
March 12 2020
Last Update
May 18 2023
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195