Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- portal pressure changes
研究概览
简要总结
To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Any gender.
- •ASA (American Society of Anesthesiologists) Classification( Class I-II)
- •Patients undergoing major elective hepatobiliary surgery.
排除标准
- •Preoperative renal failure (GFR < 50 ml/min).
- •Severe liver dysfunction (Child- turcotte -Pugh grade C).
- •Hyponatremia (<132 mmol/l).
- •Severe aortic regurgitation, severe mitral regurgitation, heart failure.
- •Symptomatic coronary heart disease.
- •Bradycardic arrhythmia (heart rate < 60/min).
- •Peripheral artery occlusive disease (clinical stadium II-IV).
- •Uncontrolled arterial hypertension (Blood pressure >160/100 mmHg despite intensive treatment).
- •Pregnancy.
研究组 & 干预措施
Terlipressin
Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.
干预措施: terlipressin (Drug)
CONTROL
Patients receive the same volume of 0.9% saline in place of terlipressin for the same duration(50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours).
干预措施: normal saline (Drug)
结局指标
主要结局
portal pressure changes
时间窗: intraoperative period
portal pressure changes in mmHg
次要结局
- Renal impairment(for 3 days in the postoperative period)
- Effect on systemic vascular resistance(intraoperative period)
- Blood units transfused(intraoperative period)
研究者
Magdy Mohammed Mahdy Sayed
Effect of terlipressin and hepatic hemodynamics during hepatobiliary surgery infusion on systemic.
Assiut University