The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty

April 26, 2022 updated by: Hospital for Special Surgery, New York
The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily related to decrease in blood pressure and secondary to fluid loading during hypotensive anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aim of this prospective study is to collect serial hemoglobin levels intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous fluid substitution will change hemoglobin levels during the time the tourniquet is inflated (no blood loss).

The combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time.

Tubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet inflation and in PACU as well as POD 1.

Study Type

Observational

Enrollment (Actual)

35

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients scheduled for primary total knee arthroplasty who meet the qualifications will be consented prior to the surgery.

Description

Inclusion Criteria:

  • Non- inflammatory degenerative joint disease of the knee
  • Patients scheduled for unilateral primary total Knee arthroplasty
  • Age between 40 and 80 years
  • Hypotensive spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
  • Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.

Exclusion Criteria:

  • Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
  • Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
  • Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
  • Congestive Heart Failure (at least one medication to treat congestive heart failure)
  • Coronary artery disease (s/p bypass, stent or AMI)
  • Kidney insufficiency (creatinine > 1.5)
  • Aortic or mitral valve disease
  • Pulmonary hypertension
  • Revision Knee Surgery
  • Inadequate intravenous fluid substitution during the procedure 1.5L during 60 minutes.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anesthesia
hemoglobin
Diagnostic test: Blood drawn
Hemoglobin and Hematocrit Levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Hemoglobin (in g/dl) Levels
Time Frame: up to 48 hours after surgery
To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.
up to 48 hours after surgery
Hematocrit (g/dL) Levels
Time Frame: Up to 48 hours after surgery
To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.
Up to 48 hours after surgery

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: Friedrich Boettner, MD, Associate Professor of Orthopaedic Surgery

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 (Actual)

January 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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