Clinical trial NCT06633510: Fluid Administered According to PVI Versus Fluid Management in Laparoscopic Trendelenburg Surgeries
Official title: Comparison of Fluid Administered According to Plethysmographic Variability Index Versus Ideal Fluid Management in Laparoscopic Trendelenburg Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload Without Edema
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: İnclusion 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

Primary outcomes:
measure: PI (perfusion index)
timeFrame: ten minutes results before induction
measure: PVI (pleth variability index)
timeFrame: ten minutes results before induction
measure: SPO2 (hemoglobin functional oxygen saturation)
timeFrame: ten minutes results before induction
measure: PR (pulse rate beats per minute)
timeFrame: ten minutes results before induction
measure: PI (perfusion index)
timeFrame: ten minutes when c02 insufflation is performed into the abdomen
measure: PVI (pleth variability index)
timeFrame: ten minutes when c02 insufflation is performed into the abdomen
measure: SPO2 (hemoglobin functional oxygen saturation)
timeFrame: ten minutes when c02 insufflation is performed into the abdomen
measure: PR (pulse rate beats per minute)
timeFrame: t2(ten minutes when c02 insufflation is performed into the abdomen
measure: PI (perfusion index)
timeFrame: two hours during the surgery in the trendelenburg position
measure: PVI (pleth variability index)
timeFrame: two hours during the surgery in the trendelenburg position
measure: SPO2 (hemoglobin functional oxygen saturation)
timeFrame: two hours during the surgery in the trendelenburg position
measure: PR (pulse rate beats per minute)
timeFrame: two hours during the surgery in the trendelenburg position
measure: PI (perfusion index)
timeFrame: five minute send of surgery
measure: PVI (pleth variability index)
timeFrame: five minute send of surgery
measure: SPO2 (hemoglobin functional oxygen saturation)
timeFrame: five minute send of surgery
measure: PR (pulse rate beats per minute)
timeFrame: five minute send of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: ANKARA ETLİK CİTY HOSPİTAL
name: ELA ERDEM HIDIROGLU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
citation: Ghoundiwal D, Delaporte A, Bidgoli J, Forget P, Fils JF, Van der Linden P. Effect of pneumoperitoneum on dynamic variables of fluid responsiveness (Delta PP and PVI) during Trendelenburg position. Saudi J Anaesth. 2020 Jul-Sep;14(3):323-328. doi: 10.4103/sja.SJA_737_19. Epub 2020 May 30.
citation: Agerskov M, Thusholdt ANW, Holm-Sorensen H, Wiberg S, Meyhoff CS, Hojlund J, Secher NH, Foss NB. Association of the intraoperative peripheral perfusion index with postoperative morbidity and mortality in acute surgical patients: a retrospective observational multicentre cohort study. Br J Anaesth. 2021 Sep;127(3):396-404. doi: 10.1016/j.bja.2021.06.004. Epub 2021 Jul 3.
citation: Yildiz GO, Hergunsel GO, Sertcakacilar G, Akyol D, Karakas S, Cukurova Z. Perioperative goal-directed fluid management using noninvasive hemodynamic monitoring in gynecologic oncology. Braz J Anesthesiol. 2022 May-Jun;72(3):322-330. doi: 10.1016/j.bjane.2021.12.012. Epub 2022 Feb 1.