Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anesthesia | hemoglobin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood drawn | Diagnostic Test | Hemoglobin and Hematocrit Levels |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
All patients scheduled for primary total knee arthroplasty who meet the qualifications will be consented prior to the surgery.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Friedrich Boettner, MD | Associate Professor of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Data
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Anesthesia | hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Anesthesia | hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels |
| 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 | The Hemoglobin (in g/dl) Levels | To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA. | Posted | Mean | Standard Deviation | g/dl | up to 48 hours after surgery |
|
|
2 days following surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anesthesia | hemoglobin Blood drawn: Hemoglobin and Hematocrit Levels | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Friedrich Boettner | Hospital for Special Surgery | 2127742127 | BoettnerF@hss.edu |
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Primary | Hematocrit (g/dL) Levels | To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA. | Posted | Mean | Standard Deviation | g/dl | Up to 48 hours after surgery |
|
|
|
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
Not provided
Not provided
Not provided
|
| 60 min |
|
| PACU |
|
| POD1 (24hr) |
|
| POD (48hr) |
|