Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Prostatic Neoplasm; Urinary Bladder Neoplasm

• Registration Number: NCT02977143
• Lead Sponsor: Seoul National University Hospital

Brief Summary

In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

Detailed Description

In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. As a preload index, the predictability of central venous pressure, pulse pressure variation and stroke volume variations may be impaired due to the impaired hemodynamics that result from the effect of increased abdominal pressure and decreased venous return. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-11-27
• Study First Posted: 2016-11-30
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-01
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy.
• American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.

Exclusion Criteria

• Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction.
• Valvular or ischemic heart disease or left ventricular ejection fraction less than 40%.
• Any significant pulmonary disease or history of chronic obstructive pulmonary disease
• End-stage renal disease or preoperative creatinine > 1.4 mg/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
fluid responsiveness	5 minutes after administration of 300 ml volulyte	fluid responsiveness is determined when increase in cardiac index is more than 10%

Secondary Outcome Measures

Name	Time	Method
arterial carbon dioxide partial pressure (mmHg)	1 minutes after the start of skin closure	arterial blood gas analysis
central venous pressure	T4: 5 minutes after administration of volulyte 300 ml	measurement of central venous pressure after fluid administration
cardiac index	T4: 5 minutes after administration of volulyte 300 ml	measurement of cardiac index after fluid administration
stroke volume variation	T4: 5 minutes after administration of volulyte 300 ml	measurement of stroke volume variation after fluid administration
abdominal pressure	T4: 5 minutes after administration of volulyte 300 ml	measurement of abdominal pressure after fluid administration
arterial oxygen partial pressure (mmHg)	1 minutes after the start of skin closure	arterial blood gas analysis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of