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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

Must not have

Any surgical case that lasted more than one hour and required general anesthesia

Patients who cannot follow a simple driving task and cannot sit on a chair for the driving test due to medical conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

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

~28870

Midazolam

2018