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Comparison of Hemodynamic Results of Two Different Fluid Managements

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05733403
Enrollment
40
Registered
2023-02-17
Start date
2022-04-01
Completion date
2023-12-01
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Fluid Management

Keywords

fluid therapy, hemodynamic parameters, The pulse contour cardiac output system, inducible nitric oxide synthetase

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.

Interventions

Isotonic solutions are IV fluids that have a similar concentration of dissolved particles as blood.

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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac indexduring surgeryCardiac 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

MeasureTime frameDescription
Number of bolus administrations of isotonic fluidduring surgeryFor 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 Episodesduring surgeryThe number of times the MAP value falls below 65mmHg during surgery
Intraoperative Fluid Balanceduring surgerythe difference between the amount of urine output and the amount of bleeding from the amount of fluid given
Plasma iNOS LevelsUp to 6 hoursdifference in serum iNOS levels preoperatively and after removal of mammoplasty material
Number of bolus administrations of noradrenalineduring surgeryFor 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.
Base deficit valueUp to 6 hoursValues measured by perioperative arterial blood gas analysis
Creatinine valuePreoperative and Postoperative 1st dayBlood level is checked on the preoperative and postoperative 1st day
Urea valuePreoperative and Postoperative 1st dayBlood level is checked on the preoperative and postoperative 1st day
Hemoglobin valuePreoperative and Postoperative 1st dayBlood level is checked on the preoperative and postoperative 1st day
Lactate valueUp to 6 hoursValues measured by perioperative arterial blood gas analysis

Countries

Turkey (Türkiye)

Contacts

Primary ContactDemet Altun Bingol, Assoc. Prof.
drdemetaltun@hotmail.com902126318767

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026