Comparison of Hemodynamic Results of Two Different Fluid Managements

Not Applicable

Recruiting

• Conditions: Perioperative Fluid Management
• Interventions: Drug: isotonic solution; Drug: Noradrenaline

• Registration Number: NCT05733403
• Lead Sponsor: Istanbul University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Status Verified: 2023-10
• Primary Completion: 2023-10-20
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Volunteering to participate in the study
2. ASA classification 1 or 2
3. The patients who will undergo reduction mammoplasty operation

Exclusion Criteria

1. Being under the age of 18 or over the age of 65
2. Presence of serious hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke Volume Variation (SVV) Group	isotonic solution	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.
Mean Arterial Pressure (MAP) Group	isotonic solution	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.
Stroke Volume Variation (SVV) Group	Noradrenaline	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.
Mean Arterial Pressure (MAP) Group	Noradrenaline	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.

Primary Outcome Measures

Name	Time	Method
Cardiac index	during surgery	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).

Secondary Outcome Measures

Name	Time	Method
Base deficit value	Up to 6 hours	Values measured by perioperative arterial blood gas analysis
Urea value	Preoperative and Postoperative 1st day	Blood level is checked on the preoperative and postoperative 1st day
Number of bolus administrations of noradrenaline	during surgery	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.
Number of bolus administrations of isotonic fluid	during surgery	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%
The Number of Hypotensive Episodes	during surgery	The number of times the MAP value falls below 65mmHg during surgery
Plasma iNOS Levels	Up to 6 hours	difference in serum iNOS levels preoperatively and after removal of mammoplasty material
Lactate value	Up to 6 hours	Values measured by perioperative arterial blood gas analysis
Intraoperative Fluid Balance	during surgery	the difference between the amount of urine output and the amount of bleeding from the amount of fluid given
Creatinine value	Preoperative and Postoperative 1st day	Blood level is checked on the preoperative and postoperative 1st day
Hemoglobin value	Preoperative and Postoperative 1st day	Blood level is checked on the preoperative and postoperative 1st day

Trial Locations

Locations (1)

Istanbul University, Department of Anesthesiology; 🇹🇷 Istanbul, Fatih, Turkey