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Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital. This type of anesthesia reduces the average arterial pressure. Benefits include reduced bleeding and lower risk of blood clots.
The purpose of this study is to determine the effect of intravenous fluids administered with hypotensive anesthesia on your blood volume. With this parameter we will be able to understand how much of your blood is lost because of bleeding and how much of the drop is related to dilution.
Study hypothesis: Hemodilution associated with intravenous fluid substitution during hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels
Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Volume Analysis, Fluid | Experimental | Preop I-131 is given and the BVA is performed, 6 hours after surgery the same procedure will be done to compare the TBV at both points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1mL of I-131 Human Serum Albumin is injected prior to the measurements | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Blood Volume | The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively. | preoperatively and 6 hours postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Change IN Plasma Volume PV | An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370- 1,295 kBq [10-30 mCi]) in saline. Measurement was performed directly before surgery in the holding area and 6 hours after surgery. Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10757582 | Background | Niemi TT, Pitkanen M, Syrjala M, Rosenberg PH. Comparison of hypotensive epidural anaesthesia and spinal anaesthesia on blood loss and coagulation during and after total hip arthroplasty. Acta Anaesthesiol Scand. 2000 Apr;44(4):457-64. doi: 10.1034/j.1399-6576.2000.440418.x. | |
| 1574972 | Background | Hahn RG. Haemoglobin dilution from epidural-induced hypotension with and without fluid loading. Acta Anaesthesiol Scand. 1992 Apr;36(3):241-4. doi: 10.1111/j.1399-6576.1992.tb03457.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Study | 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1). Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer. All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Study | 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1). Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer. All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Blood Volume | The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively. | Posted | Mean | Standard Deviation | ml | preoperatively and 6 hours postoperatively |
|
patients were monitored during length of their hospital stay and at a 4 weeks after surgery follow-up appointment. The Time Frame was 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Study | 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Friedrich Boettner | HospitalSS | 2127742127 | boettnerf@HSS.edu |
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| preoperative and 6 hours postoperatively |
| 14739801 | Background | Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016. |
| 8881630 | Background | Drobin D, Hahn RG. Time course of increased haemodilution in hypotension induced by extradural anaesthesia. Br J Anaesth. 1996 Aug;77(2):223-6. doi: 10.1093/bja/77.2.223. |
| 17496003 | Background | Manzone TA, Dam HQ, Soltis D, Sagar VV. Blood volume analysis: a new technique and new clinical interest reinvigorate a classic study. J Nucl Med Technol. 2007 Jun;35(2):55-63; quiz 77, 79. doi: 10.2967/jnmt.106.035972. Epub 2007 May 11. |
| years |
|
| Sex: Female, Male | pilot study with fixed numbers | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | Change IN Plasma Volume PV | An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370- 1,295 kBq [10-30 mCi]) in saline. Measurement was performed directly before surgery in the holding area and 6 hours after surgery. Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate. | Posted | Mean | Standard Deviation | ml | preoperative and 6 hours postoperatively |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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