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临床试验/NCT01873612
NCT01873612已完成4 期

Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Hypoxic ventilatory response

研究概览

简要总结

The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.

详细描述

15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study.

6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
  • No medication
  • No allergies
  • Non-smoker/no snuff, i.e. no nicotine intake
  • Normal weight, BMI <26

排除标准

  • 未提供

结局指标

主要结局

Hypoxic ventilatory response

时间窗: One day for each drug; before,during and after sedation with dexmeditomidine or propofol

Acute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation

次要结局

  • hypercapnic ventilatory response(One day for each drug; Before, during and after sedation with dexmedetomidine or propofol)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malin Jonsson Fagerlund

MD, PhD

Karolinska University Hospital

研究点 (2)

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