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临床试验/NCT00577200
NCT00577200进行中(未招募)4 期

The Safety of Driving in Patients After Minor Surgery With Monitored Anesthesia Care

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 625 人开始时间: 2008年1月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
625
试验地点
1
主要终点
Weaving, measured as the standard deviation of lateral position.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Midazolam + Sufentanil + Propofol

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."

干预措施: Midazolam (Drug)

Midazolam + Sufentanil + Propofol

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."

干预措施: Sufentanil (Drug)

Midazolam + Sufentanil + Propofol

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."

干预措施: Propofol (Drug)

Midazolam and Sufenatnil

Experimental

Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg.

"For subjects who are chronic pain patients undergoing minor surgical procedures."

干预措施: Midazolam (Drug)

Midazolam and Sufenatnil

Experimental

Midazolam 1-5 mg in holding area + Sufentanil 5-10 mcg.

"For subjects who are chronic pain patients undergoing minor surgical procedures."

干预措施: Sufentanil (Drug)

结局指标

主要结局

Weaving, measured as the standard deviation of lateral position.

时间窗: 6 h

次要结局

  • Reaction time (RT)(6 h)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asokumar Buvanendran

Principal Investigator

Rush University Medical Center

研究点 (1)

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