Goal-directed Fluid Management Versus Conventional Fluid Management in Laparoscopic Hysterectomy

Kanuni Sultan Suleyman Training and Research Hospital100 enrolled

Overview

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay in various kinds of surgical procedures. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay. Patients will be randomized to one of the study arms: group1 (conventional fluid management arm) will receive 0.9 % NaCl at a rate of 4- 8 mL/kg/h, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.; group 2 (GDFM); group 2 (GDFM group) will receive 0.9 % NaCl at rate of 2 mL/kg/h, a 250-mL bolus crystalloid/colloid injection will be administered when PVI is higher than 13 % over 5 min. In both groups, when MAP is still \< 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine will be administered. The groups will be compared concerning postoperative blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Surgery

Interventions

PVIDEVICE

A pulse oximetry probe which transfers data to the monitor with software able to calculate PVI data. The monitor automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III Exclusion Criteria: \- American Society of Anesthesiologists (ASA) class IV BMI \> 40 kg/m2 Non-sinus heart rhythm MAP \<65 mmHg at the onset of anesthesia induction Advanced renal and hepatic impairment Ejection fraction \< 50 % Massive bleeding in the perioperative period

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Outcomes

Primary Outcomes

creatinine (mg/dl)

Difference in serum creatinine levels between the two groups 3 hours after the operation

Time frame: 3 hours after the operation

Data from ClinicalTrials.gov

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