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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340751
• Other study ID #: 2015-081
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: September 1, 2014

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 1, 2014
• Est. primary completion date: September 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Diagnostic Test:
• Blood drawn
Hemoglobin and Hematocrit Levels

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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