Cerebral Oxygenation in Total Hip Arthroplasty Patients (THANIRS)

December 23, 2024 updated by: Hospital for Special Surgery, New York

Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty

We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Study Population

Hospital for Special Surgery patients scheduled to undergo unilateral total hip arthroplasty under hypotensive anesthesia

Description

Inclusion Criteria:

  • Patients 18-80 years old undergoing unilateral total hip arthroplasty
  • Hypotensive epidural anesthesia

Exclusion Criteria:

  • Contraindication to controlled hypotension and/or neuraxial anesthesia.
  • Severe pulmonary hypertension or pre-op systolic blood pressure reading >150 mm Hg
  • Moderate to severe valvular stenosis.
  • History of stroke, dementia, or post-op delirium
  • Prior OSA diagnosis
  • History of benzodiazepine use (regular use for longer than 3 months)
  • Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis)
  • History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK)
  • Parkinson's disease
  • Severe chronic pulmonary disease
  • Total anterior hip approach being used
  • Hip resurfacing procedure

  • Non-English Speaking*

    • Questionnaires being used to assess mental status are only validated in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THA Patients
Patients undergoing unilateral total hip arthroplasty
Device: Cerebral Oximeter
Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Other Names:
  • oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Desaturation Incidences
Time Frame: Intra-operation (when the patient enters the operating room, up to 4 hours)

The number of participant's experiencing an intra-operative cerebral oxygen desaturation event.

Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
Intra-operation (when the patient enters the operating room, up to 4 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Oxygen Desaturation
Time Frame: Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Duration of cerebral oxygen desaturation
Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Presence of Post-operative Delirium
Time Frame: Post-op Day 1, Post-op Day 2

The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition.

Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported.
Post-op Day 1, Post-op Day 2
Patients With Cognitive Dysfunction
Time Frame: Post-op Day 1, Post-op Day 2

The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog.

The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test.

  1. Three-Word Recall
  2. The Clock Drawing Test (CDT)

There are five total points a person can score on the Mini-Cog:

  • Give one point for each word that was correctly remembered. (0-3 points)
  • Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction.

Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported.
Post-op Day 1, Post-op Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Sean Garvin, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimated)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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