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

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Completed
CT.gov ID
NCT05340751
Collaborator
(none)
35
1
8
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood drawn

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
Actual Enrollment :
35 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Anesthesia

hemoglobin

Diagnostic Test: Blood drawn
Hemoglobin and Hematocrit Levels

Outcome Measures

Primary Outcome Measures

  1. The hemoglobin (in g/dl) Levels [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 (in%) levels [Up to 48 hours after surgery]

    To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
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 < 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital for Special Surgery New York New York United States 10021

Sponsors and Collaborators

  • Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Friedrich Boettner, MD, Associate Professor of Orthopaedic Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT05340751
Other Study ID Numbers:
  • 2015-081
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital for Special Surgery, New York

Study Results

No Results Posted as of Apr 22, 2022