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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 weeks
Treatment ~ Varies
Follow Up ~6 h
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 h for reporting.

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
423 Previous Clinical Trials
163,498 Total Patients Enrolled
Asokumar Buvanendran, M.D.Principal InvestigatorRush University Medical Center
2 Previous Clinical Trials
245 Total Patients Enrolled

Media Library

Sufentanil Clinical Trial Eligibility Overview. Trial Name: NCT00577200 — Phase 4
Minor Surgical Procedures Research Study Groups: Control, Midazolam + Sufentanil + Propofol, Midazolam and Sufenatnil
Minor Surgical Procedures Clinical Trial 2023: Sufentanil Highlights & Side Effects. Trial Name: NCT00577200 — Phase 4
Sufentanil 2023 Treatment Timeline for Medical Study. Trial Name: NCT00577200 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety of Driving After Minor Surgery With Monitored Anesthesia Care
Asokumar Buvanendran 2008. "Safety of Driving After Minor Surgery With Monitored Anesthesia Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00577200.
All > Anesthesia > Dsuvia
~15 spots leftby Nov 2024
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