Clinical trial

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

Name
2021/588
Description
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.
Trial arms
Trial start
2022-04-01
Estimated PCD
2023-10-20
Trial end
2023-12-01
Status
Recruiting
Treatment
isotonic solution
Isotonic solutions are IV fluids that have a similar concentration of dissolved particles as blood.
Arms:
Mean Arterial Pressure (MAP) Group, Stroke Volume Variation (SVV) Group
Other names:
0,9% NaCl
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.
Arms:
Mean Arterial Pressure (MAP) Group, Stroke Volume Variation (SVV) Group
Other names:
Norepinephrine
Size
40
Primary endpoint
Cardiac index
during surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-10-23

1 organization

2 products

1 indication