Clinical Trial

Safety of Driving After Minor Surgery With Monitored Anesthesia Care

Study acronym: MACDrive
Active, Not Recruiting Phase 4
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Summary
Patients are currently advised to refrain from driving motor vehicles or using public transportation unescorted for a 24 hour period if they undergo any minor ambulatory surgical procedure with monitored anesthesia care (MAC).However, recently introduced short-acting anesthetics may facilitate rapid recovery and an early return to normal daily activities. The proposed study will compare newer short-acting anesthetic agents (propofol, benzodiazepine, opioid) utilized in MAC, to determine if a particular pharmacological agent, or a combination of agents, impair driving performance as evaluated by driving simulator assessment, at time of discharge from the ambulatory center after minor surgical procedures.Subjects will be grouped as patients with chronic pain undergoing procedures and those without chronic pain undergoing procedures. Subjects with pain issues will be randomized with either 1)Midazolam + Sufentanil + Propofol or 2)Midazolam + Sufentanil. There will be a third group of subjects who are controls not undergoing any procedures.
Protocol Amendment History 23 amendments
This ClinicalTrials.gov record has been amended 23 times since 2007-12-19; most recent amendment 2025-12-10.
Status change: Recruiting → Active, Not Recruiting 2015-06-25
Status change: Not Yet Recruiting → Recruiting 2008-09-12
Trial Details
NCT Number NCT00577200
Lead Sponsor Rush University Medical Center
Conditions Minor Surgical Procedures With Monitored Anesthesia Care, Driving Performance After Minor Ambulatory Surgery
Enrollment 625 participants
Start Date 2008-01
Primary Completion 2026-11 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-16