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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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	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

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Friedrich Boettner, MD, Associate Professor of Orthopaedic Surgery

Study record dates

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: Total Knee Arthroplasty; Hemoglobin; Blood management; Blood transfusion; Hypotensive Anesthesia
• 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