Comparison of Hemodynamic Results of Two Different Fluid Managements

Study Overview
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Brief Summary
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In the reduction mammoplasty operations performed in the Plastic and Reconstructive surgery operating room in our clinic, the female patient group, who does not have co-morbidities and does not exceed middle age, is followed by infusion of crystalloid at a constant rate of 4 ml/kg. If the mean arterial pressure (MAP) is <65 mmHg, it is treated with fluid boluses, and in cases where no response is obtained, with noradrenaline boluses. However, in this process, frequent and severe hypotensive episodes are observed, especially after removal of more than a few kilograms of breast tissue. In these hypotensive episodes, factors other than the blood volume lost with the tissue may also play a role. For this reason, we aimed to evaluate the iNOS levels by assuming that the blood levels of inducible nitric oxide synthetase (iNOS), which is stored in large amounts in adipose tissues and has been shown to play a role in lipid metabolism, may increase with the manipulation of breast tissue, and accordingly increased nitric oxide may lead to hypotension.

Detailed Description
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The main purpose of intraoperative fluid therapy is to optimize intravascular volume, mean arterial pressure (MAP) and cardiac output, while ensuring tissue perfusion, while not causing dehydration and fluid overload in the patient. While hypovolemia may cause problems such as organ perfusion disorders and ischemia; Hypervolemia may lead to pulmonary edema, cardiac load, prolonged need for mechanical ventilation and susceptibility to related infections. Although fluid management in the perioperative period has been extensively studied in many studies, a standard practice has not been established. The amount considered restrictive in some studies may be liberal in others. In recent years, the use of dynamic parameters, which are formed as a result of cardiopulmonary interactions and whose high sensitivity and specificity have been proven by many studies, has been increasing day by day for the evaluation of intravascular volume. Pulse pressure variation(PPV) and stroke volume variation(SVV) are two of these dynamic parameters. The pulse contour cardiac output (FloTrac) system, which is a fairly newly developed method that calculates cardiac output and stroke volume directly from the arterial waveform, is used for measurement without the need for calibration. In the reduction mammoplasty operations performed in the Plastic and Reconstructive surgery operating room in our clinic, the female patient group, who does not have co-morbidities and does not exceed middle age, is followed by infusion of crystalloid at a constant rate of 4 ml/kg. If the mean arterial pressure (MAP) is <65 mmHg, it is treated with fluid boluses, and in cases where no response is obtained, with noradrenaline boluses. However, in this process, frequent and severe hypotensive episodes are observed, especially after removal of more than a few kilograms of breast tissue. In these hypotensive episodes, factors other than the blood volume lost with the tissue may also play a role. For this reason, we aimed to evaluate the iNOS levels by assuming that the blood levels of inducible nitric oxide synthetase (iNOS), which is stored in large amounts in adipose tissues and has been shown to play a role in lipid metabolism, may increase with the manipulation of breast tissue, and accordingly increased nitric oxide may lead to hypotension.

Official Title
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Comparison of Hemodynamic Results of Two Different Fluid Managements in Reduction Mammoplasty Operation

Conditions
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Perioperative Fluid Management

Intervention / Treatment
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* Drug: isotonic solution
* Drug: Noradrenaline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteering to participate in the study ASA classification 1 or 2 The patients who will undergo reduction mammoplasty operation Exclusion Criteria: Being under the age of 18 or over the age of 65 Presence of serious hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stroke Volume Variation (SVV) Group<br>When SVV value ≥ 14%, 250cc isotonic will be given within 10min. 250cc isotonic boluses will be repeated until the SVV drops below 14%. If MAP< 65 mmHg despite the SVV falling below 14%, a bolus of 4mcg noradrenaline(NA) will be administered. During the operation, if the SVV is below 14% and the MAP is < 65mmHg, a bolus of 4mcg NA will be administered. Intraoperative balance, amount of bleeding, number of fluid boluses and NA administrations, total additional fluid and NA amount, total number of hypotensive episodes will be recorded. The times when the breast tissue was removed, the weights of the removed tissues and the amount of bleeding will be recorded. Basal and 3 more arterial blood gases will be taken when the breast tissue is removed and early postoperatively, and Hgb, lactate, and base excess values will be recorded. iNOS values in blood will be recorded after basal iNOS and breast tissue are removed. The creatinine value will be recorded on the 1st postoperative day. | Drug: isotonic solution<br>* Isotonic solutions are IV fluids that have a similar concentration of dissolved particles as blood.<br>* Other names: 0,9% NaCl;Drug: Noradrenaline<br>* Noradrenaline itself is classified as a sympathomimetic drug: its effects when given by intravenous injection of increasing heart rate and force and constricting blood vessels make it very useful for treating medical emergencies that involve critically low blood pressure.<br>* Other names: Norepinephrine;|
| Active Comparator: Mean Arterial Pressure (MAP) Group<br>If MAP value under below 65mmHg, 250ml isotonic will be given within 10 min. However, if MAP is still below 65mmHg, a bolus of 4mcg NA will be administered, if no response, 4mcg NA will be repeated. If MAP falls below 65mmHg again, 250 ml isotonic will be administered again in 10 min; if it does not improve, 4mcg of NA will be given iv. Intraoperative balance, amount of bleeding, number of fluid boluses and NA administrations, total additional fluid and NA amount, total number of hypotensive episodes will be recorded. The times when the breast tissue was removed, the weights of the removed tissues and the amount of bleeding will be recorded. Basal and 3 more arterial blood gases will be taken when the breast tissue is removed and early postoperatively, and Hgb, lactate, and base excess values will be recorded. iNOS values in blood will be recorded after basal iNOS and breast tissue are removed. The creatinine value will be recorded on the 1st postoperative day. | Drug: isotonic solution<br>* Isotonic solutions are IV fluids that have a similar concentration of dissolved particles as blood.<br>* Other names: 0,9% NaCl;Drug: Noradrenaline<br>* Noradrenaline itself is classified as a sympathomimetic drug: its effects when given by intravenous injection of increasing heart rate and force and constricting blood vessels make it very useful for treating medical emergencies that involve critically low blood pressure.<br>* Other names: Norepinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index | Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA),thus relating heart performance to the size of the individual. The unit of measurement is litres per minute per square metre (L/min/m2). | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bolus administrations of noradrenaline | For the MAP group, if MAP is still below 65 mmHg despite a bolus of 250ml isotonic fluid, a bolus of 4mcg noradrenaline will be administered, if no response, 4mcg noradrenaline will be repeated. For the SVV Group, a 4 mcg bolus of noradrenaline will be given if MAP< 65 mmHg despite the SVV falling below 14% with isotonic boluses. | during surgery | 
| Number of bolus administrations of isotonic fluid | For the MAP group, the number of administrations of 250 ml of isotonic fluid delivered in 10 minutes when MAP < 65 mmHg For the SVV group, the number of administrations of 250 ml of isotonic fluid administered in 10 minutes when SVV≥ 14% | during surgery | 
| The Number of Hypotensive Episodes | The number of times the MAP value falls below 65mmHg during surgery | during surgery | 
| Intraoperative Fluid Balance | the difference between the amount of urine output and the amount of bleeding from the amount of fluid given | during surgery | 
| Plasma iNOS Levels | difference in serum iNOS levels preoperatively and after removal of mammoplasty material | Up to 6 hours | 
| Lactate value | Values measured by perioperative arterial blood gas analysis | Up to 6 hours | 
| Base deficit value | Values measured by perioperative arterial blood gas analysis | Up to 6 hours | 
| Creatinine value | Blood level is checked on the preoperative and postoperative 1st day | Preoperative and Postoperative 1st day | 
| Urea value | Blood level is checked on the preoperative and postoperative 1st day | Preoperative and Postoperative 1st day | 
| Hemoglobin value | Blood level is checked on the preoperative and postoperative 1st day | Preoperative and Postoperative 1st day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid therapy, hemodynamic parameters, The pulse contour cardiac output system, inducible nitric oxide synthetase