Minor Surgical Procedures With Monitored Anesthesia CarePhase 4MACDriveNCT00577200
Safety of Driving After Minor Surgery With Monitored Anesthesia Care
A Phase 4 study testing Midazolam, Sufentanil and Propofol in people with Minor Surgical Procedures With Monitored Anesthesia Care and Driving Performance After Minor Ambulatory Surgery, run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Minor Surgical Procedures With Monitored Anesthesia Care, Driving Performance After Minor Ambulatory Surgery
- What is being tested?
- Midazolam, Sufentanil and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: The Safety of Driving in Patients 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Dormicum, Hypnovel, Midacum, Versed
Midazolam
SufentanilDrug
Also called Sufenta
Sufentanil
PropofolDrug
Also called Diprivan
Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group. |
| Midazolam + Sufentanil + Propofol | Experimental | Midazolam 0.03 mg/kg + Sufentanil 0.1 µg/kg + Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
"For subjects who are chronic pain patients undergoing minor surgical procedures." Receives: Drug: Midazolam; Drug: Sufentanil; Drug: Propofol |
| Midazolam and Sufenatnil | Experimental | Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg.
"For subjects who are chronic pain patients undergoing minor surgical procedures." Receives: Drug: Midazolam; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaving, measured as the standard deviation of lateral position.
Measured: 6 h
Secondary outcomes (1)
Reaction time (RT)
Measured: 6 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Surgical Procedures With Monitored Anesthesia CareStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asokumar Buvanendran, Rush University Medical Center
- Investigators
- Asokumar Buvanendran, M.D., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577200
- Sponsor's protocol ID
- ABuv110507
- Acronym
- MACDrive
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2007
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT00577200
- Acronym / sponsor ID
- MACDrive / ABuv110507
- Conditions
- Minor Surgical Procedures With Monitored Anesthesia Care, Driving Performance After Minor Ambulatory Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group. |
| Midazolam + Sufentanil + Propofol | Experimental | Drug: Midazolam, Drug: Sufentanil, Drug: PropofolMidazolam 0.03 mg/kg + Sufentanil 0.1 µg/kg + Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min. "For subjects who are chronic pain patients undergoing minor surgical procedures." |
| Midazolam and Sufenatnil | Experimental | Drug: Midazolam, Drug: SufentanilMidazolam 1-5 mg in holding area + Sufentanil 5-10 mcg. "For subjects who are chronic pain patients undergoing minor surgical procedures." |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Dormicum, Hypnovel, Midacum, VersedMidazolam | Drug | Midazolam + Sufentanil + Propofol, Midazolam and Sufenatnil |
| SufentanilAlso: SufentaSufentanil | Drug | Midazolam + Sufentanil + Propofol, Midazolam and Sufenatnil |
| PropofolAlso: DiprivanPropofol bolus of 300 µg/kg + infusion at 75 µg/kg/min. | Drug | Midazolam + Sufentanil + Propofol |
Primary outcome
Weaving, measured as the standard deviation of lateral position.
Time frame: 6 h
1 secondary outcome
Reaction time (RT)
Time frame: 6 h
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asokumar Buvanendran, M.D. principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam, Sufentanil and Propofol in people with Minor Surgical Procedures With Monitored Anesthesia Care and Driving Performance After Minor Ambulatory Surgery, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaving, measured as the standard deviation of lateral position. (time frame: 6 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.