Clinical Trials in Egypt / NCT07626151
Recruiting Not applicable

Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy

NCT07626151 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-06-05
Last updated
2026-06-08

Condition(s) studied

Prostate CancerSurgeryFluid OverloadLactate Blood Increase

Investigational drug(s) / intervention(s)

Liberal Fluid TherapyRestricted Fluid Therapy

Liberal Fluid Therapy: Patients will receive 6 ml/kg/hour of lactated ringer for maintenance in addition to fasting hours compensation (2 ml/kg for each fasting hour, given as 50% in the first hour of surgery, then 25% during the second \& third hours). An additional bolus of 200 ml Lactated Ringer will be given if MAP is below 65 mmHg. In case of persistent hypotension despite proper fluid rescuistation, 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will start at initial dose 0.01mcg/kg/min if MAP is below 65 mmHg.

Restricted Fluid Therapy: Patients will receive 2 ml/kg as fluid bolus then 2 ml/kg/hour for maintenance, aiming at a target SVV less than 13 %. Patients with SVV ≥ 13% will be considered fluid responder and will receive a fluid bolus of 200 ml Ringer Lactated Ringer over 10 minutes.The fluid bolus will be repeated until the SVV is less than 13%. In case of persistent hypotension (MAP less than 65mmHg), 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will be started at intial dose 0.01mcg/kg/min if MAP is below 65 mmHg.

Study summary

Fluid therapy during surgery is an important factor that is related to long term mortality and morbidity and it's directly related to tissue perfusion as well. The main target in any surgery is what is the optimum fluid therapy to maintain the tissue perfusion and the precise balance between hazardous effects of hypervolemia that may cause delayed wound healing due to surgical anastomosis disruption or being hypovolemic that may cause tissue ischemia as acute kidney injury.

Fluid management guidance changed from static methods like central venous pressure into dynamic methods like pulse pressure variation (PPV) and stroke volume variation (SVV), which are now the most famous dynamic measures.

Electrical cardiometry is a non-invasive cardiac output monitor which uses electrical cardiometry, now a commonly used device, to measure SVV which can be used to guide fluid therapy during surgeries.

Now robotic assisted surgery is a common method in preforming many surgeries especially urological, since it's associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function.

With considerations related to severe Trendelenburg position and increased intra-abdominal pressure due to pneumo-peritoneum, robotic assisted surgeries are associated with many challenges in anesthesia especially the fluid therapy.

Fluid therapy in robotic surgeries is an area with growing research focus that need further exploration while there are established guidelines for fluid management in traditional surgeries, the optimal protocols for robotic surgeries are less well defined, needing more research.

We aim at this study to investigate the impact of liberal versus restricted fluid intake on the tissue perfusion reflected by serum lactate \& creatinine clearance, while guiding therapy through electrical cardiometry, to reach optimum fluid protocol in prostatic robotic surgeries.

Eligibility

Sex
MALE
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Male patient undergoing robotic assisted prostatectomy * ASA I-III Exclusion Criteria: * ASA score more than III * BMI more than 40 * Severe renal disease (GFR between 15 and 29) * Previous renal surgery. * Decompensated cardiac disease (NYHA class 3 or 4)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cairo University Hospitals Cairo Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07626151 on ClinicalTrials.gov ↗ ← All trials in Egypt