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临床试验/NCT04131361
NCT04131361已完成不适用

Ultrasound-guided Inferior Vena Cava Diameter Dependent Colloid Challenge Versus Routine Crystalloid Strategy Fluid Replacement in Transurethral Resection Prostate (TURP) Under Spinal Anesthesia; A Prospective Randomized Controlled Study.

Mansoura University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
total iv fluids

研究概览

简要总结

Background: Intravenous fluid replacement during transurethral resection of the prostate is still unclear. Ultrasonography of the inferior vena cava (IVC) has been recently used to assess the volume status and predict fluid responsiveness. In this double-blind, randomized controlled study, we will assess the IVC at baseline and at subsequent time points after spinal anesthesia, and according to IVC diameter will give the replacement challenge colloid. Potential problems during TURP are mostly due to either fluid overload or bleeding: Intraoperative TURP syndrome, Hemorrhage, Myocardial ischemia, Hypothermia, Prostatic capsular perforation, Bladder or urethral perforation. Postoperative TURP syndrome, myocardial ischemia/infarction, Postoperative cognitive impairment. Study Hypothesis: Strict colloid volume optimization using US-guided IVC diameter calculation aiming decrease the total IV fluid volume and accommodate the transurethral inevitable absorption of currently used irrigation crystalloid fluid (Nacl0.9%) that accidentally absorbed and change it from a circulatory overload to a complementary part of the replacement IV fluids preventing fluid overload and TURP syndrome. Aim of the work: To reduce Intraoperative and postoperative fluid overload during TURP surgery with hemodynamic stability relaying up on US-guided IVC diameter dependent Strict IV Colloid replacement volume optimization. Methods: A prospective randomized controlled trial on ASAI-III male patient aged 40-80 years old subjected to transurethral endoscopic resection of the prostate (TURP) surgery. Then patients will be divided into 2 groups according to the IV infusion fluid type as follow: Crystalloid -control group: (preload plus continuous IO Ringer acetate crystalloid 4/2/1 rule infusion) according to the usual 4/2/1 rule. Not guided by IVC diameter but IVC diameter will be calculated using the US and recorded at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery. Loop Diuretic (Furosemide) will be given according to the maximum diameter of the IVC as follow; 10mg if IVC>2.5Cm. Colloid- study group: (preload plus colloid challenge only); Fluid challenge boluses of 250 mL (over 5 minutes using a pressurizer) 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) if the IVC<1.7(higher limit of normal) will be given guided by IVC diameter at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Patients subjected to transurethral resection of prostate TURP.
  • ASA I&II
  • Age 40-80years old. prostate size 45-100
  • Surgical procedure: laser and Bipolar TURP using saline 0,9% irrigation.

排除标准

  • Height <150 cm.
  • Weight <60 kg.
  • Body mass index ≥45 kg/m
  • Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection).
  • Uncontrolled; Diabetes mellitus, cardiovascular failure, cerebrovascular uncontrolled deficite, or other renal disease.
  • Hemoglobin <10 gm/dL.
  • International Normalized Ratio >1.4
  • Platelet count <100,000 /mm
  • Preoperative serum creatinine >1.5 mg/dL

结局指标

主要结局

total iv fluids

时间窗: just after end of surgery

次要结局

  • serum Na at end of surgery(just after end of surgery)
  • serum K at end of surgery(just after end of surgery)
  • Incidence of bradycardia(serial during surgery)
  • Incidence of hypo-tension(serial during surgery)
  • ximum and minimum IVC diameter(serial during surgery)
  • IVC-CI(serial during surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Abd Latif Ghanim

Associate Professor os anesthesia ICU & Pain medicine.

Mansoura University

研究点 (2)

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