Overview

This trial is active, not recruiting.

Conditions minor surgical procedures with monitored anesthesia care., driving performance after minor ambulatory surgery.
Treatments midazolam, sufentanil, propofol
Phase phase 4
Sponsor Rush University Medical Center
Start date January 2008
End date December 2017
Trial size 625 participants
Trial identifier NCT00577200, ABuv110507

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Control group subjects are not undergoing any surgical procedures and will not be randomized to any anesthetic drug group.
(Experimental)
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."
midazolam Dormicum, Hypnovel, Midacum, Versed
Midazolam
sufentanil Sufenta
Sufentanil
propofol Diprivan
Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
(Experimental)
Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg. "For subjects who are chronic pain patients undergoing minor surgical procedures."
midazolam Dormicum, Hypnovel, Midacum, Versed
Midazolam
sufentanil Sufenta
Sufentanil

Primary Outcomes

Measure
Weaving, measured as the standard deviation of lateral position.
time frame: 6 h

Secondary Outcomes

Measure
Reaction time (RT)
time frame: 6 h

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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

Additional Information

Official title The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care
Principal investigator Asokumar Buvanendran, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Rush University Medical Center.