Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum sodium level measured in mEq/L
研究概览
简要总结
This study is designed to investigate the usage & effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications
详细描述
The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs [mean BP, HR, CVP & oxygen saturation (spO2)] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA class I - III BPH patients
排除标准
- •Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.
- •Electrolyte imbalance,
- •Uncontrolled hypertension,
- •Congestive heart failure or being allergic to local anesthetics.
研究组 & 干预措施
Group B (Hypertonic saline)
patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.
干预措施: NaCl 3% HS (Drug)
Group C (Normal saline)
patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.
干预措施: NaCl 0.9% NS (Drug)
Group A (Hypertonic saline )
patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.
干预措施: NaCl 3% HS (Drug)
结局指标
主要结局
Serum sodium level measured in mEq/L
时间窗: 72 hours
Hyponatremia was defined as a serum sodium \< 130 mEq/L
次要结局
- Need for ICU admission(72 hours)
- Incidence of TURP syndrome(72 hours)
研究者
Ahmed Mohamed ELbadawy
Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University
Kasr El Aini Hospital