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临床试验/NCT01788202
NCT01788202终止不适用

An Observational, Prospective Study in Patients With Positive Urine Cocaine Metabolites Undergoing Surgery for General Anesthesia

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
cardiac arrythmia

研究概览

简要总结

When it is safe to administer general anesthesia to the patient with cocaine positive urine drug screen has never been clearly determined. The study doctors would like to determine the effect of cocaine on blood pressure, heart rate and rhythm during surgery. After surgery, the subjects will be observed in regards to mental status and any changes in heart rate and rhythm.

详细描述

The risks associated with administering general anesthesia to cocaine abusing patients with a positive urine cocaine metabolite is a major cause of cancellation of surgery in many trauma centers. Although many clinicians wait 24 to 48 hours after a positive urine drug screen before administering anesthesia, no standard or practical guidelines have yet to determine when it is safe to proceed with general anesthesia in this patient population. Due to the lack of guidelines for these cases, the rate of cancellation of procedures for these patients is high. The frequent cancelling of such cases causes a waste of resources, personnel, and time. The risks associated with cocaine use that cause most clinicians to cancel cases are mainly due to the cardiovascular effects of cocaine. Increases in blood pressure, heart rate, temperature, and the potential for myocardial infarction and fatal arrhythmias are what clinicians fear when administering general anesthesia to these patients. However, due to the urgency of some of the cases, it would be beneficial to both the patient and institutions to know when it is safe to proceed with the case and when it is not. When it is safe to administer general anesthesia to the patient with cocaine positive urine drug screen has never been clearly determined. This observational study will evaluate the effects of general anesthesia on the cocaine abusing patient with cocaine positive urine drug screen.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists rating of 1-111
  • Positive cocaine metabolite
  • urgent surgery for acute abdomen, orthopedic trauma, maxillary-facial trauma

排除标准

  • Failure to provide consent
  • females who are pregnant

结局指标

主要结局

cardiac arrythmia

时间窗: intraoperatively

Did the patient require rescue medication for cardiac arrythmia such as tachycardia or ST segment elevation on EKG strip

次要结局

  • hypotension(intraoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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