Comparison of Hemodynamic Results of Two Different Fluid Managements

NCT05733403 | Unknown

• 1 other identifier: 2021/588
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Fluid Management

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of bolus administrations of noradrenaline

  during surgery

• Number of bolus administrations of isotonic fluid

  during surgery

• The Number of Hypotensive Episodes

  during surgery

• Intraoperative Fluid Balance

  during surgery

• Plasma iNOS Levels

  Up to 6 hours

Study Arms (2)

Stroke Volume Variation (SVV) Group

ACTIVE COMPARATOR

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.

Drug: isotonic solution; Drug: Noradrenaline

Mean Arterial Pressure (MAP) Group

ACTIVE COMPARATOR

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.

Drug: isotonic solution; Drug: Noradrenaline

Interventions

isotonic solution DRUG

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

Also known as: 0,9% NaCl

Mean Arterial Pressure (MAP) Group; Stroke Volume Variation (SVV) Group

Noradrenaline 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.

Also known as: Norepinephrine

Mean Arterial Pressure (MAP) Group; Stroke Volume Variation (SVV) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study
• ASA classification 1 or 2
• The patients who will undergo reduction mammoplasty operation

You may not qualify if:

• Being under the age of 18 or over the age of 65
• Presence of serious hypertension

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 22906292 RESULT

• 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.

  PMID: 31672462 RESULT

MeSH Terms

Interventions

Isotonic Solutions; Norepinephrine

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ceren Yılmaz, Resident

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Demet Kıvanç, researcher

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Ali E Çamcı, Prof.

  Istanbul University

  STUDY DIRECTOR

Central Study Contacts

Demet Altun Bingol, Assoc. Prof.

CONTACT

902126318767; drdemetaltun@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending anesthesiologist

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: February 17, 2023
• Study Start: April 1, 2022
• Primary Completion: October 20, 2023
• Study Completion: December 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

TU (1)