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The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care (MACDrive)
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.
Details
| Lead sponsor | Rush University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 625 |
| Start date | 2008-01 |
| Completion | 2026-12 |
Conditions
- Minor Surgical Procedures With Monitored Anesthesia Care
- Driving Performance After Minor Ambulatory Surgery
Interventions
- Midazolam
- Sufentanil
- Propofol
Primary outcomes
- Weaving, measured as the standard deviation of lateral position. — 6 h
Countries
United States