Clinical trial NCT05733403: Comparison of Hemodynamic Results of Two Different Fluid Managements
Official title: Comparison of Hemodynamic Results of Two Different Fluid Managements in Reduction Mammoplasty Operation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perioperative Fluid Management
Keywords: fluid therapy
hemodynamic parameters
The pulse contour cardiac output system
inducible nitric oxide synthetase
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac index
timeFrame: during surgery
Secondary outcomes:
measure: Number of bolus administrations of noradrenaline
timeFrame: during surgery
measure: Number of bolus administrations of isotonic fluid
timeFrame: during surgery
measure: The Number of Hypotensive Episodes
timeFrame: during surgery
measure: Intraoperative Fluid Balance
timeFrame: during surgery
measure: Plasma iNOS Levels
timeFrame: Up to 6 hours
measure: Lactate value
timeFrame: Up to 6 hours
measure: Base deficit value
timeFrame: Up to 6 hours
measure: Creatinine value
timeFrame: Preoperative and Postoperative 1st day
measure: Urea value
timeFrame: Preoperative and Postoperative 1st day
measure: Hemoglobin value
timeFrame: Preoperative and Postoperative 1st day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
state: Fatih
Study officials:
affiliation: Istanbul University
name: Ceren Yılmaz, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Demet Kıvanç, researcher
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Ali E Çamcı, Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.