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

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ClinicalTrials.gov Identifier: NCT00577200
Recruitment Status : Active, not recruiting
First Posted : December 20, 2007
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Minor Surgical Procedures With Monitored Anesthesia Care Driving Performance After Minor Ambulatory Surgery Drug: Midazolam Drug: Sufentanil Drug: Propofol Phase 4

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care
Actual Study Start Date : January 2008
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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Arms and Interventions
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Arm Intervention/treatment
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."

 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
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."

 Drug: Midazolam
Midazolam
Other Name: Dormicum, Hypnovel, Midacum, Versed

Drug: Sufentanil
Sufentanil
Other Name: Sufenta


Outcome Measures
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Primary Outcome Measures :
  1. Weaving, measured as the standard deviation of lateral position. [ Time Frame: 6 h ]

Secondary Outcome Measures :
  1. Reaction time (RT) [ Time Frame: 6 h ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577200


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Asokumar Buvanendran, M.D. Rush University Medical Center
More Information
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Responsible Party: Asokumar Buvanendran, Principal Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00577200     History of Changes
Other Study ID Numbers: ABuv110507
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Propofol
Midazolam
Sufentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
 Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents