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临床试验/NCT03113045
NCT03113045Unknown不适用

Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy

Royal Victoria Hospital, Canada2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Hypotension

研究概览

简要总结

The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.

详细描述

The study will use a Biased Coin Design (BCD), up-and-down sequential method, to determine the ET90 for absence of hypotension during Cesarean delivery. In this methodology, the first patient will be assigned an a priori initial seated time. Any other patient will be assigned a seated time based on the presence or absence of hypotension in the previous patient. If the previous patient developed hypotension, then the new patient will be seated for a longer time, which will be equal to the seated time of the previous patient plus a pre-determined time increment (up to an also pre-determined maximum allowed time). If no hypotension occurred to the previous patient, the new patient will be assigned one seated time from two choices: The same seated time that has been assigned to the previous patient, or a seated time shorter than that of the previous patient by a pre-determined time decrement (the pre-determined time increment and decrement are the same). The choice will be determined from a biased coin result, with a probability of 0.9 for assigning 'the same as previous' seated time and a probability of 0.1 for assigning a 'shorter seated time'.

研究设计

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

盲法说明

The observer will not be made aware of the time that the patient will sit.

入排标准

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

入选标准

  • Patients with singleton pregnancies scheduled for elective cesarean delivery

排除标准

  • Unable to communicate in study language
  • ASA greater than 2
  • Hypertensive disease of pregnancy

结局指标

主要结局

Hypotension

时间窗: 30 minutes

Presence of hypotension before delivery

次要结局

未报告次要终点

研究者

发起方
Royal Victoria Hospital, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Moore

Principle Investigator

Royal Victoria Hospital, Canada

研究点 (2)

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