Novel Vital-sign Patient-assisted Intravenous Analgesia With Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration: a Prospective Cohort Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maternal desaturation
研究概览
简要总结
This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia
详细描述
This study trials a new Vital signs-controlled patient-assisted intravenous analgesia (VPIA) regimen using a purpose-built pump that aims to enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. The system studies the parturient's pattern of analgesic use in 15 minute epochs and titrates the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.
The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pump and step down doses accordingly when predefined critical values are reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who choose to use parenteral opioid for pain relief with informed consent
- •Patients who refuse labour epidural analgesia or with contraindication to epidural analgesia (eg. thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)
- •Gestational age of >= 36 weeks
排除标准
- •Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
- •Patients with difficulty in communication due to language differences
- •Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogue
- •Patients with severe respiratory disease
- •Patients with history of drug dependence of recreational drug abuse
- •Patients with unmanaged foetal bradycardia
研究组 & 干预措施
Remifentanil
Remifentanil Patient Controlled Analgesia
干预措施: Remifentanil (Drug)
结局指标
主要结局
Maternal desaturation
时间窗: Duration of labour
次要结局
- Maternal bradycardia(Duration of labour, an expected average of 24 hours)
- Apnoea/hypopnoea(Duration of labour, an expected average of 24 hours)