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

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
Study Start Date :	January 2008
Estimated Primary Completion Date :	July 2018
Estimated Study Completion Date :	July 2018

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, Senior)
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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Locations

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

Principal Investigator:	Asokumar Buvanendran, M.D.	Rush University Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	September 28, 2017
Last Verified:	September 2017

Additional relevant MeSH terms:

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