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Clinical Trials/NCT03699696
NCT03699696
Completed
Not Applicable

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

Yale University1 site in 1 country541 target enrollmentDecember 1, 2014

Overview

Phase
Not Applicable
Intervention
Propofol
Conditions
Acute Kidney Injury
Sponsor
Yale University
Enrollment
541
Locations
1
Primary Endpoint
Overdose
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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. This research will be done via analysis of data and associated records contained in the Multicenter Perioperative Outcomes Group databases at Yale (the latter is a research database approved under HIC#1206010438). The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas for quality improvement in induction practices for elderly patients at YNHH and elsewhere.

Registry
clinicaltrials.gov
Start Date
December 1, 2014
End Date
July 8, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Propofol

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.

Intervention: Propofol

85+ years of age

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

Intervention: Propofol

Outcomes

Primary Outcomes

Overdose

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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