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临床试验/NCT01092923
NCT01092923已完成4 期

Nitrous Oxide and Inhalational Agent Pharmacokinetics During Anaesthetic Induction and Emergence

Austin Health1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Austin Health
入组人数
20
试验地点
1
主要终点
Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)

研究概览

简要总结

Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the unique properties of nitrous oxide have maintained its place in modern practice, where it is used in combination with other, more powerful inhaled agents, such as sevoflurane. It has useful analgesic properties, unlike the other agents used today, and its inclusion reduces the concentration of other agents required to maintain an adequate depth of anaesthesia for surgery.

In particular, its low solubility in body tissues gives it a unique pharmacokinetic profile, with rapid washin and washout from the body. It has been shown to have a similar effect on the speed of uptake of accompanying agents like sevoflurane (the "second gas effect"), which have much slower pharmacokinetics. A recent study by us suggested that this promotes faster and smoother onset of anaesthesia, as measured using the standard monitor of depth of anaesthesia (the BIS monitor). This finding requires confirmation prospectively in a larger group of patients. The investigators further hypothesise that a similar effect also exists on washout of sevoflurane at the end of the procedure, promoting quicker recovery (emergence) from anaesthesia. This has never been previously demonstrated. This information will help better define the place of nitrous oxide in achieving optimal outcomes in modern anaesthetic practice. The investigators propose to conduct a simple study to measure the effects of nitrous oxide washin and washout on exhaled concentrations of accompanying sevoflurane during both induction of anaesthesia and emergence, and identify any accompanying effect on the rate of change in depth of anaesthesia using BIS. The investigators hypothesise that the rate of fall of exhaled sevoflurane concentration at the end of anaesthesia will be more rapid in the group of patients breathing a gas mixture containing nitrous oxide, and that the rate of fall of BIS on induction and the rate of rise of BIS on emergence will be faster in the nitrous oxide group.

详细描述

Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the unique properties of nitrous oxide have maintained its place in modern practice, where it is used in combination with other, more powerful inhaled agents, such as sevoflurane. It has useful analgesic properties, unlike the other agents used today, and its inclusion reduces the concentration of other agents required to maintain an adequate depth of anaesthesia for surgery. In particular, its low solubility in body tissues gives it a unique pharmacokinetic profile, with rapid washin and washout from the body. It has been shown to have a similar effect on the speed of uptake of accompanying agents like sevoflurane (the "second gas effect"), which have much slower pharmacokinetics.

A recent study by us suggested that this promotes faster and smoother onset of anaesthesia, as measured using the standard monitor of depth of anaesthesia (the BIS monitor). This finding requires confirmation prospectively in a larger group of patients.

We further hypothesise that a similar effect also exists on washout of sevoflurane at the end of the procedure, promoting quicker recovery (emergence) from anaesthesia. This has never been previously demonstrated. This information will help better define the place of nitrous oxide in achieving optimal outcomes in modern anaesthetic practice.

We propose to conduct a simple study to measure the effects of nitrous oxide washin and washout on exhaled concentrations of accompanying sevoflurane during both induction of anaesthesia and emergence, and identify any accompanying effect on the rate of change in depth of anaesthesia using BIS.

Consenting adult participants will be recruited who are undergoing general anaesthesia for elective surgery anticipated to take a minimum of 1 hour and where an arterial line is considered appropriate for monitoring of blood pressure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Adult patients undergoing elective general or orthopaedic surgery under relaxant general anaesthesia anticipated to take >1 hour

排除标准

  • Age under 18 years
  • Morbid obesity BMI > 35
  • Severe or moderately severe lung disease (FEV1 < 1.0L, FEV1/FVC < 50%)
  • Past history of severe post-operative nausea and vomiting
  • Pregnancy

研究组 & 干预措施

Air/Oxygen

Experimental

Sevoflurane with Air/Oxygen Mix

干预措施: sevoflurane on air/O2 (Drug)

sevoflurane in N2O/O2

Experimental

干预措施: sevoflurane in N2O/O2 (Drug)

结局指标

主要结局

Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)

时间窗: Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence

Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)

PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)

时间窗: Baseline, 2 minutes, and 5 minutes after emergence

Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)

次要结局

  • Time to Eye Opening(20 Minutes)

研究者

发起方
Austin Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr Philip Peyton

Staff Anaesthetist

Austin Health

研究点 (1)

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