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临床试验/NCT00544947
NCT00544947已完成不适用

Observation of Respiration Following Regional Anaesthesia With Intrathecal Opioids: a Comparison Between Diamorphine and Fentanyl Combined With Postoperative Morphine PCA Using a Carbon Dioxide Tension and Pulse Oximetry Sensor (TOSCA)

NHS Greater Clyde and Glasgow1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
transcutaneous carbon dioxide tension

研究概览

简要总结

Spinal Administration of opioids offers segmental analgesia, but has side effects including pruritus, nausea and vomiting, urinary retention, hypotension, and respiratory depression, both early and delayed. Many Centres in the UK now routinely use supplementation of spinal anaesthesia from bupivacaine with intrathecal fentanyl or diamorphine. If Fentanyl is used, this is usually accompanied by connection to a i.v. Morphine patient-controlled analgesia (PCA)-device in the postoperative period, whereas the use of intrathecal diamorphine seems to result in a reduction in post-operative morphine requirements, which has obviated the need for PCA devices in many centres. There has been recent controversy over which opioid is safer to use with regards to the risk of respiratory depression.1,2 The investigators want to investigate, whether intrathecal diamorphine causes less or more post-operative respiratory depression in healthy mothers undergoing elective caesarean section than intrathecal fentanyl plus post-operative morphine PCA.

详细描述

Method:

We will use transcutaneous carbon dioxide tension as our primary outcome measure of respiratory depression. Secondary outcome measures will be the oxygen-saturation, the respiratory rare, neurological status assessed by Glasgow Coma Scale (GCS) and the need for administration of naloxone and/or active airway management.

PtCO2 and SpO2 will be measured transcutaneously using the Linde TOSCA 500 Monitoring System, which is a relatively new miniaturized single sensor, that is applied to the earlobe.

There will be 2 study groups.

Group D will be patients at Princess Royal Maternity Hospital in Glasgow, where supplementation with intrathecal diamorphine 300mcg is the current anaesthetic technique of choice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 1st patient on list
  • ASA I or II
  • BMI <40 at booking
  • Term pregnancy +/- 2 weeks gestation

排除标准

  • BMI>40 at booking
  • History of Obstructive Sleep Apnoea (OSA)
  • Need for supplementation with intravenous Opioids intraoperatively
  • Conversion to GA

结局指标

主要结局

transcutaneous carbon dioxide tension

时间窗: within the first 24 hours after surgery

次要结局

  • oxygen-saturation, respiratory rate, neurological status, need for administration of naloxone and/or active airway management(within first 24 hours after surgery)

研究者

申办方类型
Other

研究点 (1)

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