Fluid Administered According to PVI Versus Fluid Management in Laparoscopic Trendelenburg Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-05-05

Brief Summary

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Investigating the ideal fluid management in Trendelenburg positions during lower abdominal laparoscopic surgeries in gynecological oncology and surgical oncology patients

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Detailed Description

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Laparoscopic lower abdominal surgeries include carbon dioxide (CO2) insufflation and an advanced Trendelenburg position with the head down. Increased intra-abdominal pressure can reduce cardiac index and cause changes in total body fluid balance. However, the head down Trendelenburg position increases intracranial pressure and preload. According to traditional fluid management, intraoperative fluid deficit is calculated according to the 4-2-1 rule, by summing up hourly basal fasting level, intraoperative losses due to degree of tissue trauma (1-2mlt/kg/h in minor surgeries, 2-4mlt/kg/h in medium surgeries, 4-8mlt/kg/h in major surgeries), blood losses, urine and losses from nasogastric tube.

Preservation of intravascular volume and thus provision of hemodynamic stability are among the factors affecting postoperative morbidity and mortality. Some studies have shown that standard fluid therapy is more than necessary. Current guidelines recommend more restrictive approaches by ensuring hemodynamic stability. Masimo, which we also use routinely in our clinic, is a device designed for continuous noninvasive monitoring of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values. In our study, in the individualization of the recommended target-oriented restrictive fluid therapy in major surgeries, by comparing the calculated fluid amount with traditional fluid management with PVI values (PVI is evaluated between 0-100.

Normavolemia 15-25 low fluid responsiveness \<15 high fluid responsiveness \>25) and when the patient's massimo pvi score is \>25, 300cc bolus fluid will be administered and fluid will be loaded at an average speed and the PVI value will be reduced below 25. When the patient's massimo PVI value is below 25, restrictive fluid therapy will be followed.(A crystalloid fluid infusion of 2 mL/kg was administered to the patients.)

The aim was to investigate the ideal fluid management in Trendelenburg positions in lower abdominal laparoscopic surgeries performed in gynecological oncology and surgical oncology patients.

Conditions

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Fluid Overload Without Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Massimo group

The patient is not given fluids until the Massimo PVI score is \>25, a 300 cc fluid bolus is given when the PVI is above 25, and fluid loading is performed at an average rate until the PVI falls below 25. If the patient's Massimo PVI is below 25, restrictive fluid therapy is applied.

Group Type ACTIVE_COMPARATOR

massimo group

Intervention Type DEVICE

masimo is a device for the continuous noninvasive measurement of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index).

standart group

intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.

Group Type ACTIVE_COMPARATOR

standart group

Intervention Type OTHER

intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.

Interventions

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massimo group

masimo is a device for the continuous noninvasive measurement of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index).

Intervention Type DEVICE

standart group

intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* between the ages of 18-80
* patients with ASA score II III
* Laparoscopic lower abdominal surgery (patients undergoing gynecological oncology and surgical oncology surgery)

Exclusion Criteria

* ASA score IV
* Patients with heart failure and chronic kidney disease
* Patients who did not agree to participate in the study
* Cases that started laparoscopically and converted to laparotomy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes