A Randomised Clinical Trial To Compare The Efficacy And Safety Of Dexmedetomidine-Ropivacaine Versus Fentanyl-Ropivacaine For Epidural Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of:
研究概览
简要总结
This study is a Randomized,Parallel Group study. This study consists of 2 groups where Group RD who will receive 0.1% Inj.Ropivacaine + 0.5mcg/ml Inj.Dexmedetomidine and Group RF who will receive 0.1% Inj. Ropivacaine +2 mcg/ml Inj. Fentanyl. 68 Primigravida in labor will be equally divided into these 2 groups of 34 each. This study will be conducted in Shri. B M Patil Medical College, Vijayapura, Karnataka, India. The primary outcome is to compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of the onset of epidural analgesia, duration of analgesia, rescue analgesic dose, Visual Analog Scale, maternal vitals such as heart rate, blood pressure, oxygen saturation. The secondary outcome is to observe Ramsay Sedation Scale of mother, APGAR score of baby and maternal side effects like pruritis, hypotension, nausea, vomiting, shivering, respiratory depression, bradycardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 19.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravida with cephalic presentation ASA grade I and II Maternal age 19 to 35 years Term gestation more than or equal to 37 weeks Single fetus Cervical dilatation more than or equal to 4 cm.
排除标准
- •Hypotension/ Hypertension Obesity Endocrine disorders Fetal compromise Preterm gestation Coagulopathies Allergy to study agents Contraindications to epidural analgesia.
结局指标
主要结局
To compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of:
时间窗: Cervical dilatation from more than or equal to 4 cm to time of delivery
The onset of epidural analgesia, duration of analgesia, rescue analgesic dose
时间窗: Cervical dilatation from more than or equal to 4 cm to time of delivery
Visual Analog Scale(VAS)
时间窗: Cervical dilatation from more than or equal to 4 cm to time of delivery
Maternal Vitals- Heart rate, Blood Pressure, Oxygen saturation
时间窗: Cervical dilatation from more than or equal to 4 cm to time of delivery
次要结局
- Ramsay Sedation Score(APGAR score of the baby)