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

Comparison of Fluid Administered According to Plethysmographic Variability Index Versus Ideal Fluid Management in Laparoscopic Trendelenburg Surgeries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06633510
Enrollment
30
Registered
2024-10-09
Start date
2024-10-15
Completion date
2025-05-05
Last updated
2025-05-09

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

Conditions

Fluid Overload Without Edema

Brief summary

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

Detailed description

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.

Interventions

DEVICEmassimo 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).

OTHERstandart 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.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PI (perfusion index)ten minutes results before inductionarterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PVI (pleth variability index)ten minutes results before inductionarterial hemoglobin functional oxygen saturation % (SpO2, pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
SPO2 (hemoglobin functional oxygen saturation)ten minutes results before inductionarterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PR (pulse rate beats per minute)ten minutes results before inductionarterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

Countries

Turkey (Türkiye)

Outcome results

None listed

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