Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pruritus
研究概览
简要总结
Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.
详细描述
The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients.
- •Age 18-80yrs.
- •Elective major abdominal surgery under general anesthesia.
排除标准
- •Refusal to participate.
- •Skin or systemic disease with itching. Any condition which precludes performing spinal injection
研究组 & 干预措施
MN group
intrathecal morphine 300 micrograms+2mg nalbuphine
干预措施: Morphine 10 MG/ML (Drug)
MN group
intrathecal morphine 300 micrograms+2mg nalbuphine
干预措施: Nalbuphine Hydrochloride 10 MG/ML (Drug)
M group
intrathecal morphine 300 micrograms
干预措施: Morphine 10 MG/ML (Drug)
结局指标
主要结局
pruritus
时间窗: 24 hours postoperatively
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
次要结局
- postoperative nausea and vomiting(24 hours postoperative)
- postoperative pain(24 hours postoperative)
- Sedation(24 hours postoperative)
研究者
Sohair Adeeb
Principle investigator
Minia University