COMPARISION OF DEXMEDETOMIDINE AND MAGNESIUM SULPHATE AS ADJUVANTS WITH HYPERBARIC ROPIVACAINE FOR SPINAL ANAESTHESIA IN INFRAUMBILICAL SURGERIES: A PROSPECTIVE RANDOMIZED DOUBLE- BLIND CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Onset and duration of sensory and motor blockade
研究概览
简要总结
Comparision of Dexmedetomidine and Magnesium sulfate as adjuvants with Hyperbaric Ropivacaine for spinal anaesthesia in infraumbilical surgeries : A Prospective Randomized Double –Blind clinical study.
As per the central limit theorem ,a sample size of at least 30 is often considered a good enough for reliable statistical inferences about the population. When a sample is 30 or greater ,the sampling distribution of the population distribution is not normal. so we will take 30 cases each in control and intervention group in our study.
| Group RD |
Inj. Hyperbaric Ropivacaine (0.75%) 2.5 ml+ Inj Dexmedetomidine 10micrograms
|Group RM
Inj. Hyperbaric Ropivacaine (0.75%) 2.5 ml+ Inj Magnesium sulphate 75mg
Primary objectives of the study are
Onset and duration of sensory and motor blockade
Secondary objectives of the study are
Post operative analgesia if VAS score greater then and equal to 4 or on patient demand as a rescue analgesia
Requirement of Rescue analgesia in 24 hours
Hemodynamic changes like HR SBP DBP MAP SPO2
Complication if any if any bradycardia hypotension nausea vomiting shivering,respiratory depression
As there is limited study available regarding efficacy of hyperbaric ropivacaine with dexmedetomidine and magnesium sulphate as an adjuvant, so we decide to do comparision of hyperbaric ropivacaine with dexmedetomidine and magnesium sulphate in infraumbilical surgeries with primary aims to onset and duration of sensory and motor blockage and secondary aims to post operative analgesia, requirement of rescue analgesia , hemodynamic stability and complication if any
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Group – 18 years to 60 years
- •ASA – I/II/III
- •Infraumbilical surgeries
- •Duration of surgery 2 to 2.5 hrs.
排除标准
- •1.Patients Refusal 2.Patient with history of previous spine surgery 3.Heart block & ventricular dysfunction 4.Patient with spine deformity 5.Patient on anticoagulant therapy 6.Patient with local site infection 7.Patients with allergy to study drugs 8.Severe hypovolemia.
结局指标
主要结局
Onset and duration of sensory and motor blockade
时间窗: Till 24 hrs
次要结局
- 1 Post operative analgesia if VAS score greater then and equal to 4 or on patient demand as a rescue analgesia(2 Requirement of Rescue analgesia in 24 hours)
研究者
DR DHARMISHTHABEN HASMUKHBHAI VASAVA
SIR SAYAJI RAO GAEKWAD HOSPITAL