NCT00577200

Safety of Driving After Minor Surgery With Monitored Anesthesia Care

The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 625 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.The three critical measures of driving performance selected are: weaving, reaction time, and number of collisions. If any of the experimental MAC conditions shows statistical equivalence at discharge with baseline, for all three criterion measures, then that anesthetic regimen can be designated as "safe to drive". If this study can demonstrate such an early recovery of driving ability, which is probably the most complex and dangerous activity commonly encountered, this begs the re-examination of all post-operative activity restrictions imposed on this patient population. 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.

Conditions

• Minor Surgical Procedures With Monitored Anesthesia Care
• Driving Performance After Minor Ambulatory Surgery

Interventions

Type	Name	Description
DRUG	Midazolam	Midazolam
DRUG	Sufentanil	Sufentanil
DRUG	Propofol	Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.

Timeline

• Start date: 2008-01-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2007-12-20
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States