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The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.
Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute.
Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %.
1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus.
End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %.
2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia.
2.2. Secondary end point(s):
A. Intraoperative adverse events:
B.Postoperative adverse events (at 48 hours)
2.2.1. Timepoint(s) of evaluation of this end point: 48 hours of surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaine Hydrochloride 0,5% | Experimental | The doses used of Levobupivacaine Hydrochloride 0.5% will be 6 mg and the dose of fentanyl 10 μg. |
|
| isobaric bupivacaine 0,5% | Active Comparator | The doses used of isobaric bupivacaine will be 6 mg and the dose of fentanyl 10 μg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine Hydrochloride 0.5% | Drug | The solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure. | The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg. | Intraoperative |
| Compare hemodynamic effects from heart rate. | The measurement of heart rate in beats per minute. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques. | 48 hours of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HERRERA Rosa, PhD | Contact | +34 659205338 | 35606rhc@gmail.com | |
| BELDA Fco Javier, Professor | Contact | +34 961.973.500 | 973847 | Fco.Javier.Belda@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| HERRERA ROSA, PhD | General University Hospital of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario | Recruiting | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| C049389 | dextran - saline drug combination |
| C037172 | Elliott's solution |
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|
| Isobaric bupivacaine 0.5% | Drug | The solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution. |
|
|
| D007869 |
| Leg Injuries |