Safety of Driving After Minor Surgery With Monitored Anesthesia Care (MACDrive)
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Purpose
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.Subjects without pain issues will be randomized with either 1)Midazolam + Propofol or 2)Sufentanil + Propofol.There will be a third group of subjects who are controls not undergoing any procedures.
| Condition | Intervention | Phase |
|---|---|---|
|
Minor Surgical Procedures With Monitored Anesthesia Care. Driving Performance After Minor Ambulatory Surgery. |
Drug: Midazolam Drug: Sufentanil Drug: Propofol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care |
- Weaving, measured as the standard deviation of lateral position. [ Time Frame: 6 h ] [ Designated as safety issue: Yes ]
- Reaction time (RT) [ Time Frame: 6 h ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 625 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.
|
|
|
Experimental: Midazolam and Propofol
Midazolam 0.03 mg/kg + Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min "For subjects who are not chronic pain patients undergoing minor surgical procedures." |
Drug: Midazolam
Midazolam
Other Name: Dormicum, Hypnovel, Midacum, Versed
Drug: Propofol
Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
Other Name: Diprivan
|
|
Experimental: Sufentanil and Propofol
Sufentanil 0.1 µg/kg + Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min. "For subjects who are not chronic pain patients undergoing minor surgical procedures." |
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 + 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
|
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.Subjects without pain issues will be randomized with either 1)Midazolam + Propofol or 2)Sufentanil + Propofol. There will be a third group of subjects who are controls not undergoing any procedures.
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Asokumar Buvanendran, M.D. | 312-942-3685 | asokumar@aol.com |
| Contact: Mario Moric | 312-942-2806 | mario_moric@rush.edu |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Asokumar Buvanendran, M.D. 312-942-3685 asokumar@aol.com | |
| Principal Investigator: | Asokumar Buvanendran, M.D. | Rush University Medical Center |
More Information
No publications provided
| Responsible Party: | Asokumar Buvanendran, Principal Investigator, Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00577200 History of Changes |
| Other Study ID Numbers: | ABuv110507 |
| Study First Received: | December 18, 2007 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anesthetics Midazolam Propofol Sufentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs |
Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013