Anesthesia
Conditions
Keywords
Blood management, Blood transfusion, Hemoglobin, Hypotensive Anesthesia, Total Knee Arthroplasty
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.
Interventions
DIAGNOSTIC_TESTBlood drawn
Hemoglobin and Hematocrit Levels
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hematocrit (g/dL) 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anesthesia hemoglobin
Blood drawn: Hemoglobin and Hematocrit Levels | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Anesthesia | — |
|---|---|---|
| Age, Continuous | 66 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Hematocrit (g/dL) Levels
To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.
Time frame: Up to 48 hours after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anesthesia | Hematocrit (g/dL) Levels | 15 min | 36.8 g/dl | Standard Deviation 3.2 |
| Anesthesia | Hematocrit (g/dL) Levels | 30 min | 36 g/dl | Standard Deviation 3.1 |
| Anesthesia | Hematocrit (g/dL) Levels | 45 min | 35.4 g/dl | Standard Deviation 2.9 |
| Anesthesia | Hematocrit (g/dL) Levels | 60 min | 34.7 g/dl | Standard Deviation 3.1 |
| Anesthesia | Hematocrit (g/dL) Levels | PACU | 35.1 g/dl | Standard Deviation 2.7 |
| Anesthesia | Hematocrit (g/dL) Levels | POD1 (24hr) | 35.3 g/dl | Standard Deviation 3.4 |
| Anesthesia | Hematocrit (g/dL) Levels | POD (48hr) | 32.6 g/dl | Standard Deviation 3.2 |
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.
Time frame: up to 48 hours after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anesthesia | The Hemoglobin (in g/dl) Levels | 15 min | 12.2 g/dl | Standard Deviation 1.2 |
| Anesthesia | The Hemoglobin (in g/dl) Levels | 30 min | 12.0 g/dl | Standard Deviation 1.2 |
| Anesthesia | The Hemoglobin (in g/dl) Levels | 45 min | 11.9 g/dl | Standard Deviation 1.595 |
| Anesthesia | The Hemoglobin (in g/dl) Levels | 60 min | 11.8 g/dl | Standard Deviation 1.3 |
| Anesthesia | The Hemoglobin (in g/dl) Levels | PACU stay | 12.0 g/dl | Standard Deviation 1 |
| Anesthesia | The Hemoglobin (in g/dl) Levels | POD1 (24hr) | 11.6 g/dl | Standard Deviation 1.2 |
| Anesthesia | The Hemoglobin (in g/dl) Levels | POD2 (48hr) | 11.0 g/dl | Standard Deviation 1.3 |