跳至主要内容
临床试验/NCT04099030
NCT04099030已完成不适用

The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 1,668 人开始时间: 2019年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,668
试验地点
1
主要终点
Total Fentanyl usage

研究概览

简要总结

This study will look at the effects of fentanyl shortage in laparoscopic cholecystectomy cases. The opioid shortage, specifically hydromorphone and fentanyl, caused a decrease in administration of opioid analgesia for laparoscopic cholecystectomy intraoperatively.

详细描述

The goal of this study is to look at the clinical impact of the drug shortage of intravenous (IV) opioids from 2016 to 2018. IV opioids are used in the hospital setting ranging from the Emergency Department to the Intensive Care Unit (ICU) to the Operating room. This study will look at the usage of IV opioids in the operating room setting and determine how practice has change in the setting of drug shortage. The study team hypothesizes that the average monthly consumption of fentanyl and hydrophone would have been decreased for laparoscopic cholecystectomy intraoperatively during the opioid shortage period as compared to before the shortage period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • All Genders
  • History of laparoscopic cholecystectomy
  • American Society of Anesthesiologist classification (ASA) 1-4 emergent and Non emergent
  • Adult >18 years old
  • Wake Forest Baptist Medical Center Main Operating rooms

排除标准

  • Regional Anesthetic
  • ASA 5 and 6

结局指标

主要结局

Total Fentanyl usage

时间窗: June 2018 to May 2019

Monthly average amount administered per case per kg

次要结局

  • Number of reintubation incidents(June 2018 to May 2019)
  • Number of CPR incidents(June 2018 to May 2019)
  • Number of incidents requiring administration of emergency drugs(June 2018 to May 2019)
  • Nonopioid analgesia usage(June 2018 to May 2019)
  • Length of hospital stay(June 2018 to May 2019)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验