Comparison of Hemodynamic Results of Two Different Fluid Managements

Perioperative Fluid Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733403
• Other study ID #: 2021/588
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2023
• Source: Istanbul University
• Contact: Demet Altun Bingol, Assoc. Prof.
• Phone: 902126318767
• Email: drdemetaltun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Fluid Management

Intervention

Drug:
• isotonic solution
Isotonic solutions are IV fluids that have a similar concentration of dissolved particles as blood.
• Noradrenaline
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.

Locations

Country	Name	City	State
Turkey	Istanbul University, Department of Anesthesiology	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Anavi S, Tirosh O. iNOS as a metabolic enzyme under stress conditions. Free Radic Biol Med. 2020 Jan;146:16-35. doi: 10.1016/j.freeradbiomed.2019.10.411. Epub 2019 Oct 28. — View Citation

Li J, Ji FH, Yang JP. Evaluation of stroke volume variation obtained by the FloTrac/Vigileo system to guide preoperative fluid therapy in patients undergoing brain surgery. J Int Med Res. 2012;40(3):1175-81. doi: 10.1177/147323001204000338. — View Citation

Outcome

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