CompletedNot Applicable

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

United States35 participantsStarted 2014-01-01

Plain-language summary

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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Hemoglobin (in g/dl) Levels

Timeframe: up to 48 hours after surgery

Hematocrit (g/dL) Levels

Timeframe: Up to 48 hours after surgery

Trial details

NCT IDNCT05340751

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-09-01

Results submitted2022-04-26

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