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)
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
- 是
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)
