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临床试验/NCT03086694
NCT03086694已完成不适用

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月5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
60
试验地点
1
主要终点
blood loss measurement

研究概览

简要总结

Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss during operation, the patients are often under intentional hypotension. However, the intentional hypotension may confuse with hypovolemic induced low blood pressure. The hypothesis is using flotrac (to measure stroke volume variation) to keep the patients hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid or colloid and prevent hypovolemia induced postoperative nausea and vomiting.

详细描述

Orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicated surgery that undergoes several hours with nasotracheal intubation general anesthesia. Patients without premedication undergo orthognathic surgery with nasotracheal intubation general anesthesia.

Patients without premedications Monitoring of patients with entropy for consciousness, ECG, with noninvasive BP and invasive blood pressure through redial artery, train-of-four monitor, target controlled infusion of propofol, infusion Tridil, and sevoflurane for mainly anesthesia maintenance. Ventilator setting as volume control (8-12ml/kg), frequency respiratory rate (8-12/min), I/E ratio: 1/2, positive end expiratory pressure: 4 mmHg, Fraction inspiratory O2: 60%.

To maintain the MAP >60-55 mmHg, urine output 0.5-1ml/kg, and body core temperature > 36 Celsius degree.

Closely observation of patients postoperatively for adverse events or complications.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergo orthognathic surgery, ASA I~III, 20 to 65 years old, no mouth limitation

排除标准

  • ankylosing spondylitis, limited mouth opening < 3 cm, liver or renal disease, obese patients (BMI>35kg/m2), patients refused

结局指标

主要结局

blood loss measurement

时间窗: 10hrs

to maintain low blood pressure (MAP \> 55mmHg) to limit blood loss

次要结局

  • assessment of inappropriate fluid infusion(10hours)
  • postoperative adverse events(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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