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临床试验/NCT01431612
NCT01431612已完成1 期

The Effects of ß1-receptor Blockade and α1-adrenergic Agonist on the Kinetics of Lactated Ringer's Solution During Surgery

Sodertalje Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Urinary excretion

研究概览

简要总结

The aim this study was to examine to what degree the slow turnover of lactated Ringer's solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed under intravenous anesthesia.

详细描述

INTRODUCTION The renal clearance of infused crystalloid fluid is very low during anaesthesia and surgery, but experiments in conscious sheep indicate that the renal fluid clearance might approach a normal rate when the adrenergic balance is modified.

METHODS Sixty females (mean age, 32 years) undergoing laparoscopic gynecological surgery were randomized to control group and received only the conventional anesthetic drugs and 20 ml/kg of lactated Ringer's over 30 min. The others were also given an infusion of 50 µg/kg/min of esmolol (beta1-receptor blocker) or 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours. The distribution and elimination of infused fluid was studied by volume kinetic analysis based on urinary excretion and blood Hgb level.

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
Single (Care Provider)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA group I
  • Scheduled for laparoscopic removal of ovarian cyst or laparoscopic hysterectomy

排除标准

  • ASA group > I
  • Daily medication

研究组 & 干预措施

Esmolol

Active Comparator

50 µg/kg/min of the ß-1-receptor-blocker esmolol (Qilu Pharmaceutical Co, Shandong, China) wss infused intravenously over 3 hours

干预措施: Esmolol administration (Drug)

Phenylephrine

Active Comparator

Intravenous infusion of 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic agonist) over 3 hours.

干预措施: Phenylephrine infusion (Drug)

Lactated Ringer´s solution

Placebo Comparator

10 ml/h lactated Ringer's solution without active drug was infused intravenously over 3 hours.

干预措施: Lactated Ringer´s solution (Drug)

结局指标

主要结局

Urinary excretion

时间窗: 3 hours

Urine was collected via an indwelling catheter during 3 hours of surgery

次要结局

  • Volume kinetics of lactated Ringer´s solution(3 hours)

研究者

发起方
Sodertalje Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Hahn

Investigator

Sodertalje Hospital

研究点 (1)

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