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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether new short-acting anesthetics, such as Midazolam (also known as Versed, Hypnovel, or Dormicum), Propofol, and Sufentanil, allow patients to drive safely sooner after minor surgeries. It compares different drug combinations used during surgery to assess their impact on driving skills using a driving simulator. Individuals with chronic pain undergoing minor surgeries, such as those on the hand, arm, or leg, might be suitable candidates. Participants must have a valid driver's license and will undergo tests on their driving performance. A comparison group of individuals not undergoing surgery will also participate. As a Phase 4 trial, this research aims to understand how these FDA-approved anesthetics can benefit more patients in real-world settings.

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 is the safety track record for these treatments?

Research has shown that using midazolam, sufentanil, and propofol together is generally safe for short surgeries. Propofol acts quickly and wears off fast. Studies indicate that at low doses, it has little effect on driving ability, potentially allowing for faster recovery.

For the combination of midazolam and sufentanil, research indicates it is safe and effective for light sedation during procedures. However, midazolam can sometimes delay the return of coordination, so driving is usually not advised immediately afterward.

Both combinations have been used safely in medical settings, but it is important to follow any specific safety instructions from healthcare professionals after receiving these medications. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores how different anesthesia combinations affect driving performance after minor surgeries. Unlike standard treatments, which often focus solely on patient comfort and surgical outcomes, this trial aims to understand the real-world implications of anesthesia on daily activities like driving. By comparing combinations of Midazolam, Sufentanil, and Propofol, the trial seeks to identify which anesthesia regimen allows for safer, quicker recovery to everyday tasks. This could lead to more informed choices about anesthesia options, enhancing patient safety and quality of life post-surgery.

What evidence suggests that this trial's treatments could be effective for driving performance after minor surgery?

In this trial, participants will join different treatment arms to evaluate the effects of anesthesia on driving performance after minor ambulatory surgery. One arm will receive a combination of Midazolam, Sufentanil, and Propofol. Research has shown that these three drugs together can speed up recovery after sedation. Studies have found that driving skills can return to normal within an hour after using Propofol, while Midazolam may take slightly longer. Another arm will receive Midazolam and Sufentanil, both reliable and effective for sedation, commonly used in medical settings for quick recovery. Overall, these drugs act quickly to help patients resume daily activities sooner. ^{3 5 6 7 8}

Who Is on the Research Team?

Asokumar Buvanendran, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0885392498000244

Stability of Midazolam and Fentanyl in Infusion Solutions When midazolam and fentanyl are combined, both agents are apparently more than 90% stable for up to 3 hr at room temperature, but the stability of this ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537321/

Midazolam - StatPearls - NCBI Bookshelf - NIH Midazolam is a short-acting benzodiazepine frequently used for anesthesia induction, seizure management, and procedural sedation.

3. cdt.amegroups.org cdt.amegroups.org/article/view/137385/html

Effectiveness of intravenous administration of a combination of ... The combined administration of sufentanil and esketamine effectively managed pain and significantly reduced depressive symptoms in post-cardiac surgery ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0294418

Operational outcomes of propofol sedation versus fentanyl ... Statistically significant decreases in SSSI of 2.5, 2.1, and 2.2 minutes for upper, lower, and dual GI procedures were observed when using MAC protocols.

5. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(23)00694-3/fulltext

a systematic review and network meta-analysis of ... Compared with midazolam-opioids, recovery time was shorter with propofol (mean difference 16.3 min, 95% confidence interval [CI] 8.4–24.3 fewer ...

6. jtd.amegroups.org jtd.amegroups.org/article/view/32448/html

Safety and efficacy of sufentanil combined with midazolam in ... Conclusions: Sufentanil combined with midazolam was safe and effective for bronchoscopy under conscious sedation. Keywords: Conscious sedation; midazolam; ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6837946/

Safety and efficacy of sufentanil combined with midazolam ... Conclusions. Sufentanil combined with midazolam was safe and effective for bronchoscopy under conscious sedation.

8. mayoclinic.org mayoclinic.org/drugs-supplements/fentanyl-injection-route/description/drg-20075614

Fentanyl (injection route) - Side effects & uses Fentanyl injection is used to relieve severe pain during and after surgery. It is also used with other medicines just before or during an operation.