Comparison of Hemodynamic Results of Two Different Fluid Managements

NCT ID: NCT05733403

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-01

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.

Conditions

Perioperative Fluid Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stroke Volume Variation (SVV) Group

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.

Group Type: ACTIVE_COMPARATOR

isotonic solution

Intervention Type: DRUG

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

Noradrenaline

Intervention Type: DRUG

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.

Mean Arterial Pressure (MAP) Group

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.

Group Type: ACTIVE_COMPARATOR

isotonic solution

Intervention Type: DRUG

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

Noradrenaline

Intervention Type: DRUG

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.

Interventions

isotonic solution

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

0,9% NaCl; Norepinephrine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Demet Altun

attending anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ceren Yılmaz, Resident

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Demet Kıvanç, researcher

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Ali E Çamcı, Prof.

Role: STUDY_DIRECTOR

Istanbul University

Locations

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Demet Altun Bingol, Assoc. Prof.

Role: CONTACT

drdemetaltun@hotmail.com

902126318767

Facility Contacts

Demet Altun, MD

Role: primary

drdemetaltun@hotmail.com

00905326811767

References

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.

Reference Type: RESULT

PMID: 22906292 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31672462 (View on PubMed)

Other Identifiers

2021/588

Identifier Type: -

Identifier Source: org_study_id