Safety of Driving After Minor Surgery With Monitored Anesthesia Care - Full Text View

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. 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

Resource links provided by NLM:

Drug Information available for: Propofol Midazolam maleate Midazolam hydrochloride Sufentanil citrate

U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

Weaving, measured as the standard deviation of lateral position. [ Time Frame: 6 h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reaction time (RT) [ Time Frame: 6 h ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	625
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (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 + 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. 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 (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577200

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


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:	April 26, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016

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