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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Hypotension; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: Propofol

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.

• Study Type: Observational
• Enrollment (Actual): 541

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale New Haven Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent induction of general anesthesia at YNHH, looking specifically at elderly patients undergoing gynecology-oncology surgeries with intubation and propofol induction.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Propofol; Induction of anesthesia prior to surgery with propofol; Other Names: Diprivan
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.	Drug: Propofol; Induction of anesthesia prior to surgery with propofol; Other Names: Diprivan
85+ years of age; Patients who are 85 years of age or older, and receive propofol for induction of anesthesia.	Drug: Propofol; Induction of anesthesia prior to surgery with propofol; Other Names: Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overdose	Percentage of patients >=65 who received greater than the FDA approved induction dosage of propofol	Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	Mean arterial pressure of less than 60mmHg	Between time of induction of anesthesia and surgical incision as detailed in the patient's anesthesia record
Acute kidney injury	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.	Within 7 days postoperatively

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Eric Y Chen, BS, Yale University

Publications and helpful links

General Publications

• Chen EY, Michel G, Zhou B, Dai F, Akhtar S, Schonberger RB. An Analysis of Anesthesia Induction Dosing in Female Older Adults. Drugs Aging. 2020 Jun;37(6):435-446. doi: 10.1007/s40266-020-00760-3.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): July 8, 2018
• Study Completion (Actual): July 8, 2018

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: elderly; acute kidney injury; hypotension; induction; anesthetic dosing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 2000023458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No