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

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: PVI

• Registration Number: NCT03970928
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2019-08-02
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
goal-directed fluid management (GDFM)	PVI	A pulse oximetry probe will be connected to the fourth finger of the hand in which there was not an arterial catheter in all patients and it will be wrapped so that it would not be affected by the external light. The pulse oximeter will then be connected to a monitor including the PVI software which automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor. 0.9 % NaCl at a rate of 2 mL/kg/h will be infused in PVI- guided GDFM group, a 250-mL bolus crystalloid/colloid injection will be administered when PVI was higher than 13 % over 5 min.

Primary Outcome Measures

Name	Time	Method
creatinine (mg/dl)	3 hours after the operation	Difference in serum creatinine levels between the two groups 3 hours after the operation

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Please Enter The State Or Province, Turkey