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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-80
SponsorNazmy Edward Seif

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male patient undergoing robotic assisted prostatectomy

ASA I-III

Disqualifiers

ASA score more than III

BMI more than 40

Severe renal disease (GFR between 15 and 29)

Previous renal surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liberal Fluid Therapy

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Liberal GroupActive comparator 1 intervention
Group B: Restricted GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum Lactate level difference

Serum Lactate level difference between pre-operative (baseline) value and post-operative (recovery) value in mmol/L

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nazmy Edward Seif

Lead sponsor

Cairo University

Sponsor institution