Effect of Adding Dexmedetomidine to Bupivacain _fentanyl Mixture in Spinal Analgesia for Normal Labour
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0
研究概览
简要总结
To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour
详细描述
Effect of adding dexmedetomidine to bupivacain fentanyl mixture in spinal analgesia for normal labour
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of patint is between 18 and 40 years. gestational age of fetus is more than 37 weeks. singleton viable fetus and cephalic presentation. spontaneous labor with cervix dilation more than 5cm.
排除标准
- •Drug allergy. Blood Disease. Infection at site of injection. patient takes anticoagulants. patient has pre-eclampsia ,cardiac disease (NYHA III-IV) or diabetes mellitus type I prior to the pregnancy patients refuse
研究组 & 干预措施
DEX
Participants receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with dexmedetomidine 2.5 µg and fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions.
干预措施: injecting dexmedetomidine (Drug)
CONTROLLED
Participants will receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions.
干预措施: injecting mixture of bupivacaine fentanyl (Drug)
结局指标
主要结局
changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0
时间窗: baseline
evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )
duration of sensory blockade
时间窗: 5 minutes after injection of analgesic agents till normal delivery done
change in numeric pain intensity score ( NPIS )
changes in numeric pain intensity score ( NPIS )
时间窗: 5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents
Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain
次要结局
未报告次要终点
研究者
Mohamed Ragab Mohamed
residant
Minia University Hospital