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临床试验/NCT02331108
NCT02331108已完成不适用

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

Albert Einstein Healthcare Network1 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
331
试验地点
1
主要终点
Measurement of Core Temperature

研究概览

简要总结

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

详细描述

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.

研究设计

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

入排标准

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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

sevoflurane in 100% oxygen, age <56

Active Comparator

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.

干预措施: Selection of anesthetic induction technique (Drug)

sevoflurane in 50% nitrous, age <56

Active Comparator

The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.

干预措施: Selection of anesthetic induction technique (Drug)

propofol, age <56

Active Comparator

The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.

干预措施: Selection of anesthetic induction technique (Drug)

propofol with phenylephrine, age <56

Active Comparator

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.

干预措施: Selection of anesthetic induction technique (Drug)

sevoflurane in 100% oxygen, age >55

Active Comparator

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.

干预措施: Selection of anesthetic induction technique (Drug)

sevoflurane in 50% nitrous, age >55

Active Comparator

The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.

干预措施: Selection of anesthetic induction technique (Drug)

结局指标

主要结局

Measurement of Core Temperature

时间窗: intraoperative

Core temperature at 15 minute intervals

Temperature Below 36.0 Degrees C

时间窗: Intraoperative

Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia

次要结局

  • Measurement of Blood Pressure(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Roth

Staff Anesthesiologist, M.D.

Albert Einstein Healthcare Network

研究点 (1)

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