Monitored Anesthesia Care for Driving Performance After Minor Ambulatory Surgery
(MACDrive Trial)
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.12345Why 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.35678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo minor surgical procedures with monitored anesthesia care using different anesthetic regimens
Driving Assessment
Participants' driving performance is evaluated using a driving simulator at the time of discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
Active Control
Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg. "For subjects who are chronic pain patients undergoing minor surgical procedures."
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."
Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Published Research Related to This Trial
Citations
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 ...
Midazolam - StatPearls - NCBI Bookshelf - NIH
Midazolam is a short-acting benzodiazepine frequently used for anesthesia induction, seizure management, and procedural sedation.
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 ...
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.
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 ...
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; ...
Safety and efficacy of sufentanil combined with midazolam ...
Conclusions. Sufentanil combined with midazolam was safe and effective for bronchoscopy under conscious sedation.
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.
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