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

NCT03699696 | Completed

• 1 other identifier: 2000023458
• Study Type: observational
• Target: 541
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Hypotension; Anesthesia; Adverse Effect

Keywords

acute kidney injury; hypotension; anesthetic dosing; induction; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hypotension

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

• Acute kidney injury

  Within 7 days postoperatively

Study Arms (3)

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

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

85+ years of age

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

Drug: Propofol

Interventions

Propofol DRUG

Induction of anesthesia prior to surgery with propofol

Also known as: Diprivan

65-75 years of age; 75-85 years of age; 85+ years of age

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Health System

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  PMID: 32300966 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Hypotension

Interventions

Propofol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Eric Y Chen, BS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: December 1, 2014
• Primary Completion: July 8, 2018
• Study Completion: July 8, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)