跳至主要内容
临床试验/NCT03699696
NCT03699696已完成不适用

A Pilot Analysis of the Association Between Anesthesia Induction Dosing and Acute Kidney Injury (AKI) in the Elderly Population

Yale University1 个研究点 分布在 1 个国家目标入组 541 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
541
试验地点
1
主要终点
Overdose

研究概览

简要总结

This study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia and its association with the development of hypotension and AKI among elderly patients at YNHH.

详细描述

The first stage of this study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia. We will determine the percent (as a function of age, Elixhauser score, ASA status) of patients who receive more than the FDA approved induction dosage. We estimate 30% with the power defined as the width of the 95 percent confidence interval around that number that is given by 80% power and n=500.

In the second stage, the investigators will look at the association between dose and the development of hypotension (in the time after induction and before surgical incision) and post-operative AKI among elderly patients at YNHH while controlling for age, Elixhauser score, and ASA status. The results of this study will also hopefully be used in a quality improvement project to prevent overdosing of the elderly patient population with induction anesthetic.

Hypothesis 1: Elderly patients are being overdosed (per FDA guidelines) with anesthetic agents for induction of general anesthesia.

Hypothesis 2: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing AKI.

Hypothesis 3: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing hypotension post-induction, which may contribute to development of AKI or vice-versa.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 65 or older who underwent induction of general anesthesia at YNHH
  • Only first surgery for each patient within the time period is counted
  • Only include patients who underwent intubation
  • Only include patients who underwent induction by propofol bolus
  • Only include patients who got at least 0.3mg/kg of propofol

排除标准

  • Patients under the age of 65, patients who underwent monitored anesthetic care/conscious mediation for their procedures.
  • Patients with renal failure and/or chronic kidney disease
  • Patients who have a pre-operative systolic blood pressure <100

研究组 & 干预措施

65-75 years of age

Patients who are between the ages of 65 and 75, including 65 but not including 75, and receive propofol for induction of anesthesia.

干预措施: Propofol (Drug)

75-85 years of age

Patients who are between the ages of 75 and 85, including 75 but not including 85, and receive propofol for induction of anesthesia.

干预措施: Propofol (Drug)

85+ years of age

Patients who are 85 years of age or older, and receive propofol for induction of anesthesia.

干预措施: Propofol (Drug)

结局指标

主要结局

Overdose

时间窗: Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record

Percentage of patients \>=65 who received greater than the FDA approved induction dosage of propofol

次要结局

  • Acute kidney injury(Within 7 days postoperatively)
  • Hypotension(Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验