Safety of Driving After Minor Surgery With Monitored Anesthesia Care (MACDrive)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00577200
First received: December 18, 2007
Last updated: August 26, 2014
Last verified: August 2014

December 18, 2007
August 26, 2014
January 2008
December 2014   (final data collection date for primary outcome measure)
Weaving, measured as the standard deviation of lateral position. [ Time Frame: 6 h ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00577200 on ClinicalTrials.gov Archive Site
Reaction time (RT) [ Time Frame: 6 h ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety of Driving After Minor Surgery With Monitored Anesthesia Care
The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care

Patients are currently advised to refrain from driving motor vehicles or using public transportation unescorted for a 24 hour period if they undergo any minor ambulatory surgical procedure with monitored anesthesia care (MAC).However, recently introduced short-acting anesthetics may facilitate rapid recovery and an early return to normal daily activities. The proposed study will compare newer short-acting anesthetic agents (propofol, benzodiazepine, opioid) utilized in MAC, to determine if a particular pharmacological agent, or a combination of agents, impair driving performance as evaluated by driving simulator assessment, at time of discharge from the ambulatory center after minor surgical procedures.Subjects will be grouped as patients with chronic pain undergoing procedures and those without chronic pain undergoing procedures. Subjects with pain issues will be randomized with either 1)Midazolam + Sufentanil + Propofol or 2)Midazolam + Sufentanil. There will be a third group of subjects who are controls not undergoing any procedures.

Patients are currently advised to refrain from driving motor vehicles or using public transportation unescorted for a 24 hour period if they undergo any minor ambulatory surgical procedure with monitored anesthesia care (MAC).However, recently introduced short-acting anesthetics may facilitate rapid recovery and an early return to normal daily activities. The proposed study will compare newer short-acting anesthetic agents (propofol, benzodiazepine, opioid) utilized in MAC, to determine if a particular pharmacological agent, or a combination of agents, impair driving performance as evaluated by driving simulator assessment, at time of discharge from the ambulatory center after minor surgical procedures.The three critical measures of driving performance selected are: weaving, reaction time, and number of collisions. If any of the experimental MAC conditions shows statistical equivalence at discharge with baseline, for all three criterion measures, then that anesthetic regimen can be designated as "safe to drive". If this study can demonstrate such an early recovery of driving ability, which is probably the most complex and dangerous activity commonly encountered, this begs the re-examination of all post-operative activity restrictions imposed on this patient population. Subjects will be grouped as patients with chronic pain undergoing procedures and those without chronic pain undergoing procedures.Subjects with pain issues will be randomized with either 1)Midazolam + Sufentanil + Propofol or 2)Midazolam + Sufentanil. There will be a third group of subjects who are controls not undergoing any procedures.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Minor Surgical Procedures With Monitored Anesthesia Care.
  • Driving Performance After Minor Ambulatory Surgery.
  • Drug: Midazolam
    Midazolam
    Other Name: Dormicum, Hypnovel, Midacum, Versed
  • Drug: Sufentanil
    Sufentanil
    Other Name: Sufenta
  • Drug: Propofol
    Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
    Other Name: Diprivan
  • No Intervention: Control
    Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.
  • Experimental: Midazolam + Sufentanil + Propofol

    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."

    Interventions:
    • Drug: Midazolam
    • Drug: Sufentanil
    • Drug: Propofol
  • Experimental: Midazolam and Sufenatnil

    Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg.

    "For subjects who are chronic pain patients undergoing minor surgical procedures."

    Interventions:
    • Drug: Midazolam
    • Drug: Sufentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
625
March 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ambulatory surgical patient possessing a valid driving license and presenting for a minor procedure that does not physically impact ability to drive (such as hand, arm, and lower extremity surgery).
  • Another group of subjects who are not scheduled for a procedure will be given a driving simulator exercise and they will be control group.

Exclusion Criteria:

  • Any surgical case that lasted more than one hour and required general anesthesia will be excluded.
  • Patients with a history of chronic benzodiazepine or alcohol abuse, alcohol or other substance dependence or recent use of medications with sleep altering qualities, and driving simulator sickness.
  • Patients who cannot follow a simple driving task and cannot sit on a chair for the driving test due to medical conditions will also be excluded.
  • History of seizures
Both
21 Years to 70 Years
Yes
Contact: Asokumar Buvanendran, M.D. 312-942-3685 asokumar@aol.com
Contact: Mario Moric 312-942-2806 mario_moric@rush.edu
United States
 
NCT00577200
ABuv110507
No
Asokumar Buvanendran, Rush University Medical Center
Rush University Medical Center
Not Provided
Principal Investigator: Asokumar Buvanendran, M.D. Rush University Medical Center
Rush University Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP