CTRI/2020/12/029820尚未招募1 期
To Compare The Post operative Analgesia with epidural ropivacaine with or without ketamine vs magnesium sulphate for breast ontological surgeries
Sri guru ram das medical college1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- evaluate twenty four hour postoperative analgesic efficacy of magnesium sulphate 1mg/kg vs ketamine 0.5 mg/kg as adjunct to epidural ropivacaine alone in patients undergoing breast oncological surgery.
研究概览
简要总结
Due to incorporation of ketamine in schedule h its availability is a concern.so to evaluate newer drugs in post operative nalgesiq during breast oncologicql surgeries we decided to compare epidural ropivacaine with ot without magneisum sulphate with ketamine
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged 20-70 yrs.
- •with ASA grade I and II scheduled for elective Carcinoma breast surgeries.
- •2.Patients giving consent for the study.
排除标准
- •Contraindications to epidural anaesthesia: Patients with spinal deformity, local infection, unstable hemodynamics, bleeding diathesis and on anticoagulants.
- •Contraindication to study drug: Allergy, hypersensitivity, mental retardation, drug abuse, cardiac, respiratory, renal, thyroid, hepatic and CNS disorder.
结局指标
主要结局
evaluate twenty four hour postoperative analgesic efficacy of magnesium sulphate 1mg/kg vs ketamine 0.5 mg/kg as adjunct to epidural ropivacaine alone in patients undergoing breast oncological surgery.
时间窗: On arrival in the recovery room, time will be counted as 0 hours and the patient will be evaluated for vitals, pain, side effects every 30 minutes for next 2 hours and later at 4, 6, 8, 10, 12, 24 hrs.
次要结局
- Efficacy of Magnesium as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score.(2)Efficacy of Ketamine as adjunct to Ropivacaine on intensity of post operative pain using Numerical Rating Score.)
研究者
研究点 (1)
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