此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

2017年4月12日 更新者:Jonathan Roth、Albert Einstein Healthcare Network

A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane

To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane

研究概览

详细说明

Hypothermia occurs with anesthetic induction due to redistribution hypothermia. Hypothermia has adverse effects and should be avoided or minimized. Intravenous propofol induction is the most common technique used for anesthetic induction. There is preliminary evidence that there is less redistribution hypothermia when anesthetic induction is achieved by inhalation induction compared to intravenous induction. There is not enough data to compel a change in practice patterns. This study will enroll a larger number of patients in order to provide stronger evidence that there is a significant difference between induction techniques on body temperature. Patients will be randomly assigned to two variation of inhalation induction techniques and two variations of intravenous induction. The effect on temperature between the four groups will be compared. Reducing the degree of hypothermia has the potential to decrease surgical infection rate as well as providing other benefits to patients.

研究类型

介入性

注册 (实际的)

331

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19141
        • Albert EinsteinMedical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

Elective surgery Adult, age >= 18 years old Scheduled for general anesthesia Medically fit and able to safely go any of the four anesthetic inductions in the study

Exclusion Criteria:

Emergency surgery, or any other aspiration risk Minor, age <18 Pregnant Febrile illness Contraindication to nasal instrumentation Allergy to propofol Malignant hyperthermia Requiring Total Invravenous Anesthesia (TIVA) Inability to oxygenate on less than 50% FiO2 Intra-cranial surgery Receiving vasoactive medications Significant valvular heart disease Unstable cardiac disease Surgery requiring prone or lateral positioning Contraindication to nitrous oxide Prisoners

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:sevoflurane in 100% oxygen, age <56
The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
其他名称:
  • anesthesia, anesthetic induction, sevoflurane, propofol
有源比较器:sevoflurane in 50% nitrous, age <56
The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
其他名称:
  • anesthesia, anesthetic induction, sevoflurane, propofol
有源比较器:propofol, age <56
The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
其他名称:
  • anesthesia, anesthetic induction, sevoflurane, propofol
有源比较器:propofol with phenylephrine, age <56
The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
其他名称:
  • anesthesia, anesthetic induction, sevoflurane, propofol
有源比较器:sevoflurane in 100% oxygen, age >55
The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
其他名称:
  • anesthesia, anesthetic induction, sevoflurane, propofol
有源比较器:sevoflurane in 50% nitrous, age >55
The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
其他名称:
  • anesthesia, anesthetic induction, sevoflurane, propofol

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Measurement of Core Temperature
大体时间:intraoperative
Core temperature at 15 minute intervals
intraoperative
Temperature Below 36.0 Degrees C
大体时间:Intraoperative
Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia
Intraoperative

次要结果测量

结果测量
措施说明
大体时间
Measurement of Blood Pressure
大体时间:intraoperative
Blood pressure decrease after intravenous anesthetic induction
intraoperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jonathan V Roth, MD、Albert Einstein Healthcare Network

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年8月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2014年11月20日

首先提交符合 QC 标准的

2015年1月2日

首次发布 (估计)

2015年1月6日

研究记录更新

最后更新发布 (实际的)

2017年4月17日

上次提交的符合 QC 标准的更新

2017年4月12日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅