Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT00577200

Safety of Driving After Minor Surgery With Monitored Anesthesia Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory surgical patient possessing a valid driving license and presenting for a minor procedure that does not physically impact ability to drive (such as hand, arm, and lower extremity surgery).
  • Another group of subjects who are not scheduled for a procedure will be given a driving simulator exercise and they will be control group.

Exclusion criteria

  • Any surgical case that lasted more than one hour and required general anesthesia will be excluded.
  • Patients with a history of chronic benzodiazepine or alcohol abuse, alcohol or other substance dependence or recent use of medications with sleep altering qualities, and driving simulator sickness.
  • Patients who cannot follow a simple driving task and cannot sit on a chair for the driving test due to medical conditions will also be excluded.
  • History of seizures

Treatment and study plan

midazolam

Drug

Midazolam

Other names: Dormicum, Hypnovel, Midacum, Versed

Sufentanil

Drug

Sufentanil

Other names: Sufenta

Propofol

Drug

Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.

Other names: Diprivan

Primary outcomes

  1. Weaving, measured as the standard deviation of lateral position.

    Time frame: 6 h

Secondary outcomes

  1. Reaction time (RT)

    Time frame: 6 h

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: MACDrive

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2007
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.