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Comparison of Conventional Fluid Management Protocol With Targeted Pleth Variability Index (PVI) Monitoring Protocol During Total Abdominal Hysterectomy and Bilateral Salpingooferectomy Operation

NCT04775576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-07-13

No results posted yet for this study

Summary

This study aims to compare the volume management methods performed by using conventional method and PVI monitoring in intraoperative fluid treatment during bilateral salpingo-oophorectomy and total hysterectomy operation.

Conditions

  • Intraoperative Hypotension
  • Intraoperative Complications
  • Hypervolemia
  • Acute Renal Failure
  • Perioperative/Postoperative Complications
  • Volume Overload

Interventions

OTHER

Pleth Variability Index

Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively.

OTHER

Conventional fluid theraphy

8-10 ml / kg / hour iv fluid maintenance will be started for the control group. If the mean arterial pressure (MAP) is \<65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.

OTHER

Anesthesia method

All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation. Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done. In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation. After two minutes of preoxygenation, anesthesia induction will be started. Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl. Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation.

Sponsors & Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-07-12
Completion
2021-07-12

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04775576 on ClinicalTrials.gov