跳至主要内容
临床试验/NCT06510803
NCT06510803已完成不适用

Sevoflurane Concentrations During Induction of Anesthesia With the Drager Apollo and General Electric (GE) Ohmeda Workstations in Children

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia

研究概览

简要总结

The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.

详细描述

Protocol definition:

This study will not deviate from standard anesthetic management of children with the exception of recording the child's vital signs and anesthetic gas concentrations during the anesthetic induction.

Healthy children, 2-6 years of age, fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Children's Hospital in Buffalo, New York will be consented for this protocol by the principal investigator. Parents who speak English will be approached for consent; the formal hospital translator service will be used for those parents who do not speak English. The medical translator will translate the consent form for the parents.

Children will be selected for inclusion in this study from the elective surgery list. A total of 28 children of both sexes will be enrolled, 14 with each of the two workstations. We will strive to include the workstation in each operating room at least once in the study. The choice of anesthesia workstations, Drager Apollo or General Electric (GE) Ohmeda, is predetermined by the floor on which the surgery is planned. Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei.

Once the standard anesthesia monitors are applied, the children will undergo a routine inhalational induction that begins with a mixture of 5 liters/minute nitrous oxide and 2 liters/minute oxygen. Once the end-tidal nitrous oxide concentration reaches 0.45, the sevoflurane vaporizer will be dialed to 8%. The inspired and expired concentrations of sevoflurane will be recorded at the designated times (see data collection sheet) for the first 10 minutes of anesthesia. All vital signs (oxygen saturation, end-tidal carbon dioxide tension, blood pressure and heart rate) will also be recorded.All unusual movements and airway responses will also be recorded and when they occurred (under Notes on the data collection form). At the conclusion of the 10 minutes of the induction, the airway will be secured with an airway device, the surgery will proceed as planned and the recording will cease. The study will be terminated.

研究设计

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

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • scheduled for elective surgery under general anesthesia,
  • American Society of Anesthesiologists physical status 1 or 2 fasted, unpremeditated

排除标准

  • parents refuse consent
  • presence of moderate or severe cardiorespiratory disease
  • difficult airway
  • malignant hyperthermia
  • neuromuscular disorders
  • obstructive sleep apnea

研究组 & 干预措施

Control is GE Ohmeda workstation

The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia.

干预措施: The washin of sevoflurane in the GE Ohmeda workstation (Drug)

Intervention is Drager Apollo workstation

The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia.

干预措施: The washin of sevoflurane in the GE Ohmeda workstation (Drug)

结局指标

主要结局

Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia

时间窗: From 0 to 10 minutes of induction of anesthesia

We will measure the inspired and expired sevoflurane concentrations using an agent monitor, determine the ratio for each patient during each measurement at 30 seconds for the first 5 minutes of induction and and then every minute until the IV is secured. Data are reported as means and standard deviations at each of the time points and represented in a figure.

次要结局

  • Maximum Sevoflurane Concentrations During Induction of Anesthesia(10 minutes of induction of anesthesia)
  • Time to Reach 90% of the Maximum Inspired Concentration(within the first 10 minutes of induction of sevoflurane)
  • Maximum Inspired Concentration at 1 Minute of Induction(At 1 minute during induction of anesthesia)

研究者

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

Jerrold Lerman

Clinical Professor of Anesthesia

State University of New York at Buffalo

研究点 (1)

Loading locations...

相似试验