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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970928
• Other study ID #: Gulseren2
• Status: Completed
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: September 10, 2019

Study information

• Verified date: October 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 10, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Please Enter The State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creatinine (mg/dl)	Difference in serum creatinine levels between the two groups 3 hours after the operation	3 hours after the operation