Safety of Driving After Minor Surgery With Monitored Anesthesia Care (MACDrive)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00577200 |
|
Recruitment Status :
Active, not recruiting
First Posted : December 20, 2007
Last Update Posted : September 28, 2017
|
Sponsor:
Rush University Medical Center
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Anesthesia
| 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 |
Primary Outcome Measures :
- Weaving, measured as the standard deviation of lateral position. [ Time Frame: 6 h ]
Secondary Outcome Measures :
- Reaction time (RT) [ Time Frame: 6 h ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
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
| 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 |
| 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 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 |