Skip to main content
Clinical Trials/NCT05340751
NCT05340751CompletedNot Applicable

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

Hospital for Special Surgery, New York1 site in 1 country35 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
35
Locations
1
Primary Endpoint
The Hemoglobin (in g/dl) Levels

Study Overview

Brief 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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 <
  • •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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital for Special Surgery, New York
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials