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临床试验/NCT02237716
NCT02237716Unknown不适用

Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 90 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
stroke volume variation

研究概览

简要总结

The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and 10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P < 0.001), which returned to the baseline after 20 min.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria were: being aged between 16 and 70 years;
  • with a body mass index of 18-25 kg/m2;
  • with a physical status classified as ASA class I or II;
  • and scheduled for elective craniotomy

排除标准

  • Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;
  • had a previous history of intra-aortic balloon counterpulsation;
  • exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission;
  • or rejected to participate in this study.

结局指标

主要结局

stroke volume variation

时间窗: during the procedure

peripheral vascular resistance

时间窗: during the procedure

cardiac index

时间窗: during the procedure

systolic pressure

时间窗: during the procedure

central venous pressure

时间窗: during the procedure

heart rate

时间窗: during the procedure

stroke volume index

时间窗: during the procedure

次要结局

  • base excess(during the procedure)
  • lactic acid(during the procedure)
  • DO2I(during the procedure)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinxin Shao

Resident

First Affiliated Hospital, Sun Yat-Sen University

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