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

NCT ID: NCT03970928

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-02
• Study Completion Date: 2019-09-10

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

goal-directed fluid management (GDFM)

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.

Group Type: ACTIVE_COMPARATOR

PVI

Intervention Type: DEVICE

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.

Conventional fluid management group (CFMG)

This group will receive conventional fluid management described as follows: 0.9 % NaCl at a rate of 4- 8 mL/kg/h will be infused in CFGM group, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gulseren Yilmaz

Principal Investigator, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulseren Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Hospital

Locations

Kanuni Sultan Suleyman Training and Research Hospital

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

Countries

Turkey (Türkiye)

Other Identifiers

Gulseren2

Identifier Type: -

Identifier Source: org_study_id