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Monitored Anesthesia Care for Driving Performance After Minor Ambulatory Surgery (MACDrive Trial)
Phase 4
Waitlist Available
Led By Asokumar Buvanendran, M.D.
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 h
Awards & highlights
MACDrive Trial Summary
This trial will compare the effects of different anesthetics on driving ability after surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects from the anesthetics include drowsiness, slower reaction times, impaired coordination which could impact the ability to drive safely immediately following surgery.
MACDrive Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 h
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 h
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weaving, measured as the standard deviation of lateral position.
Secondary outcome measures
Reaction time (RT)
MACDrive Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Midazolam and SufenatnilExperimental Treatment2 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 + PropofolExperimental Treatment3 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: ControlActive Control1 Intervention
Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufentanil
2013
Completed Phase 4
~28610
Midazolam
2018
Completed Phase 4
~1910
Propofol
2017
Completed Phase 4
~1530
Find a Location
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
162,906 Total Patients Enrolled
Asokumar Buvanendran, M.D.Principal InvestigatorRush University Medical Center
2 Previous Clinical Trials
245 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am part of the control group and will participate in a driving simulator exercise.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.I have a valid driving license and am having minor surgery that won't affect my driving.I have a history of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Midazolam + Sufentanil + Propofol
- Group 3: Midazolam and Sufenatnil
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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