ACTRN12612000572864已完成4 期
In women receiving spinal anaesthesia including intrathecal morphine for caesarean section, is subcutaneous methylnaltrexone 12 mg given at the end of surgery more effective than placebo in reducing 24 hour pruritus severity?
King Edward Memorial Hospital for Women0 个研究点目标入组 130 人开始时间: 2012年5月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. American Society of Anesthesiologists classification 1 or 2
- •2. Elective caesarean section under spinal anaesthesia, with or without epidural catheterization
排除标准
- •1. Preoperative use of opioid medication
- •2. Contraindication to spinal anaesthesia
- •3. Preoperative pruritus for any reason
- •4. Weight outside the range 62-114 kg
- •5. Severe renal impairment, gastro-intestinal disease or diarrhoea
- •6. Conversion to another method of anaesthesia, prior to study drug, for any reason
- •7. Failure to administer intrathecal morphine
- •8. Administration of a drug with anti-pruritic activity (propofol, antihistamine, 5HT3-receptor antagonists or other drugs with opioid agonist or antagonist activity such as tramadol or naloxone) prior to study drug
- •9. Administration of epidural opioid prior to administration of study drug.
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