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临床试验/NCT03428191
NCT03428191Unknown不适用

The Research About the Target Effect-site Concentration of Remifentanil Inhibiting Stress Reaction of the Perineal Prostate Puncture When Dexmedetomidine Being Continuous Pumping

Chinese Medical Association1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
the target effect-site concentration of remifentanil

研究概览

简要总结

The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping

详细描述

Patients who were scheduled to undergo transperineal prostate puncture and biopsy were recruited into our study. In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. The first target effect-site concentration of remifentanil was set to 4.5ng/ml, the difference of adjacent target concentration was 0.5 ng/ml. Cardiovascular positive reaction was defined as the changes of heart rate or systolic blood pressure was more than 15% compared with baseline values, or body movement observed. The adjacent target concentration difference was adjusted to 0.2 ng/ml after 3 negative and positive reaction cycles. If the first had a cardiovascular positive reaction, the target concentration of remifentanil increased by a concentration gradient. Conversely, the target concentration of remifentanil decreased by a concentration gradient.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients of perineal prostate puncture

排除标准

  • sinus bradycardia or atrioventricular block serious heart, brain, lung, liver, kidney, and metabolic disease allergy for dexmedetomidine or opioid

结局指标

主要结局

the target effect-site concentration of remifentanil

时间窗: intraoperative

the target Effect-site concentration of remifentanil was determined by sequential method.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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