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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
  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:


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: March 2015
Estimated Primary Completion Date: December 2014 (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
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

Contacts
Contact: Asokumar Buvanendran, M.D. 312-942-3685 asokumar@aol.com
Contact: Mario Moric 312-942-2806 mario_moric@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Asokumar Buvanendran, M.D.    312-942-3685    asokumar@aol.com   
Sponsors and Collaborators
Rush University Medical Center
Investigators
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: August 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014