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临床试验/NCT03394833
NCT03394833已完成不适用

Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study

Umeå University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Incidence of blood pressure drops

研究概览

简要总结

The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.

详细描述

40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.

NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •80 individuals over 18 years, body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

排除标准

  • •instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.

研究组 & 干预措施

No preoperative fluids

No Intervention

40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.

Preoperative fluids

Experimental

40 individuals receiving preoperative colloid fluid bolus at 6 ml/kg LBW, (Gelofusine™, Fresenius Kabi AB, Sweden) before anesthesia induction by TCI (n = 20) or RSI (n =20).

干预措施: gelofusine (Other)

结局指标

主要结局

Incidence of blood pressure drops

时间窗: 20 minutes post anesthesia induction

blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction

Effect of preoperative fluid bolus

时间窗: 20 minutes post anesthesia induction

Does preoperative fluid bolus decrease incidence of blood pressure drops

次要结局

未报告次要终点

研究者

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

Tomi Myrberg

Principal Investigator

Umeå University

研究点 (1)

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