NCT03970928

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

Comparison of Conventional Fluid Management With Pleth Variability Index Based Goal-directed Fluid Management in Elective Laparoscopic Hysterectomies.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Surgery

Interventions

Type	Name	Description
DEVICE	PVI	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.

Timeline

• Start date: 2019-08-02
• Primary completion: 2019-09-01
• Completion: 2019-09-10
• First posted: 2019-06-03
• Last updated: 2019-10-03

Locations

1 site across 1 country: Turkey (Türkiye)