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

Официальное название

Effect Of Standard Versus Restricted Fluid Therapy Guided By Electric Cardiometry On Tissue Perfuison In Robotic Prostaectomy: A Randomized Controlled Study

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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 d

Первичные конечные точки

• Serum Lactate level difference [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• Male patient undergoing robotic assisted prostatectomy
• ASA I-III

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Египет · 1 центр

• Cairo University Hospitals — Cairo

Идентификаторы

NCT: NCT07626151 · ECGSVRFTRP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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