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Completed

NCT Number: NCT05340751

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

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.

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Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Blood drawn

Diagnostic Test

Hemoglobin and Hematocrit Levels

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2022
Registry last updated
Jan 26, 2023

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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