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Completed

NCT Number: NCT03699696

A Pilot Analysis of the Association Between Anesthesia Induction Dosing and 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Health System

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Induction of anesthesia prior to surgery with propofol

Other names: Diprivan

Primary outcomes

  1. 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

  1. Hypotension

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

    Mean arterial pressure of less than 60mmHg

  2. Acute kidney injury

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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