A Pilot Analysis of the Association Between Anesthesia Induction Dosing and AKI in the Elderly Population

Completed

• Conditions: Acute Kidney Injury; Hypotension; Anesthesia; Adverse Effect
• Interventions: Drug: Propofol

• Registration Number: NCT03699696
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2018-07-08
• Study Completion: 2018-07-08
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 541

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
65-75 years of age	Propofol	Patients who are between the ages of 65 and 75, including 65 but not including 75, and receive propofol for induction of anesthesia.
75-85 years of age	Propofol	Patients who are between the ages of 75 and 85, including 75 but not including 85, and receive propofol for induction of anesthesia.
85+ years of age	Propofol	Patients who are 85 years of age or older, and receive propofol for induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Overdose	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 Outcome Measures

Name	Time	Method
Acute kidney injury	Within 7 days postoperatively	AKI identifies when there is an increase of 1.5 times the baseline serum creatinine observed in first 7 postoperative days OR when the baseline creatinine increases greater than or equal to 0.3 mg/dl in 48 hours after anesthesia end. Baseline serum creatinine is defined as the most recent serum creatinine resulted in the last 60 days preoperatively.
Hypotension	Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record	Mean arterial pressure of less than 60mmHg

Trial Locations

Locations (1)

Yale New Haven Health System; 🇺🇸 New Haven, Connecticut, United States