Monitored Anesthesia Care for Driving Performance After Minor Ambulatory Surgery

(MACDrive Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Must not be taking: Benzodiazepines, Alcohol

Disqualifiers: Substance dependence, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

625 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a history of chronic benzodiazepine or alcohol abuse, or recent use of medications that affect sleep, you may be excluded from the trial.

What data supports the effectiveness of the drug Midazolam, Versed, Hypnovel, Dormicum, Propofol, Sufentanil for monitored anesthesia care in driving performance after minor ambulatory surgery?

Research shows that propofol, a component of the treatment, is effective for short procedures with minimal driving impairment at low concentrations. Additionally, combining midazolam with propofol has been shown to be effective and safe for outpatient anesthesia, suggesting potential benefits for monitored anesthesia care. ^{1 2 3 4 5}

Is monitored anesthesia care safe for driving performance after minor ambulatory surgery?

Midazolam and propofol, used in monitored anesthesia care, are generally safe for humans, but they can impair driving ability. Midazolam may cause memory issues and loss of driving fitness for up to twelve hours, while propofol at certain concentrations can impair driving similar to having a blood alcohol level of 0.05%. ^{1 3 5 6 7}

How does monitored anesthesia care differ from other anesthesia options for minor ambulatory surgery?

Monitored anesthesia care is unique because it involves close monitoring and can use short-acting drugs like propofol, which allow for a quick recovery and potentially faster readiness to drive after surgery compared to traditional general anesthesia. ^{1 3 5 8 9}

Research Team

Asokumar Buvanendran, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for people with a valid driving license who are having minor surgery that doesn't affect their ability to drive, like procedures not involving hands, arms, or legs. They must be able to do a driving test on a simulator. People with seizures, chronic drug or alcohol abuse, or those taking sleep-altering meds can't join.

Inclusion Criteria

I am part of the control group and will participate in a driving simulator exercise.

I have a valid driving license and am having minor surgery that won't affect my driving.

Exclusion Criteria

I had surgery under general anesthesia that lasted more than an hour.

I have no history of chronic substance abuse or recent use of sleep-altering meds.

I cannot perform simple tasks or sit for a test due to my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minor surgical procedures with monitored anesthesia care using different anesthetic regimens

1 day

1 visit (in-person)

Driving Assessment

Participants' driving performance is evaluated using a driving simulator at the time of discharge

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Midazolam
• Propofol
• Sufentanil

Trial Overview The study tests if new short-acting anesthetics (propofol, benzodiazepine, opioid) used in monitored anesthesia care affect driving skills after minor surgery. Patients will either receive Midazolam + Sufentanil + Propofol or just Midazolam + Sufentanil and then perform a simulated driving test.

Participant Groups

Group I: Midazolam and Sufenatnil Experimental Treatment 2 Interventions

Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg. "For subjects who are chronic pain patients undergoing minor surgical procedures."

Group II: Midazolam + Sufentanil + Propofol Experimental Treatment 3 Interventions

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."

Group III: Control Active Control 1 Intervention

Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

In a study evaluating the use of a single 7.5 mg tablet of midazolam as a premedicant for minor oral surgery, no significant drop in arterial oxygen saturation was observed, indicating a low risk of hypoventilation.

However, the study found that midazolam did not provide significant anxiolytic (anxiety-reducing) or amnestic (memory-blocking) effects, suggesting that its therapeutic benefits at this dosage are minimal and not recommended for widespread use due to potential complications and impaired driving ability for 12 hours post-administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The question of oral sedation using midazolam in outpatient dental surgery]. Wahlmann, UW., Dietrich, U., Fischer, W.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Driving impairment due to propofol at effect-site concentrations relevant after short propofol-only sedation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Outpatient general anesthesia: a comparison of a combination of midazolam plus propofol and propofol alone. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intravenous techniques in ambulatory anesthesia. [2019]

4. China pubmed.ncbi.nlm.nih.gov

[Application of conscious sedation with midazolam, propofol and sufentanil for patients in plastic surgery]. [2012]

5. England pubmed.ncbi.nlm.nih.gov

A comparison of diazepam and midazolam as sedatives for minor oral surgery. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

[The question of oral sedation using midazolam in outpatient dental surgery]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of intranasal administration of sedative medications (ketamine, midazolam, or sufentanil) for urgent brief pediatric dental procedures. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

General anesthetic techniques. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Perioperative physiological and cognitive functions following oral premedication with 3.75 mg midazolam in operations with retrobulbar anesthesia]. [2019]