Comparitive study between dexmedetomidine and fentanyl as adjuvants to continuous ropivacaine epidural infusion for post-operative analgesia in abdominal cancer surgeries
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To compare the efficacy and duration of post operative epidural analgesia
研究概览
简要总结
Although the limited data available suggests that dexmedetomedine as an adjuvant to continuous epidural infusion of ropivacaine has superior results in post-operative analgesia and less side-effects as compared to fentanyl. To establish this efficacy further validation and research is required. Therefore, we planned a study to determine the efficacy of both the adjuvants and compare post-operative analgesia and rescue requirement and also, dose reduction in requirement of local anaesthetic after the addition of adjuvant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient scheduled for major abdominal cancer surgeries
- •ASA grade I-III women
- •Age group 18 -70 years 4.
排除标准
- •Infection at epidural site
- •History of coagulopathy
- •Severely hypovolemic patients
- •Raised ICP
- •Refusal for epidural analgesia
- •Pre-existing neurological deficit or demyelinating disorders
- •Severe spinal deformity
- •Known allergy to local anaesthetics or fentanyl or dexmedetomedine
- •Chronic pain or long term opiods or NSAIDS usage
- •Those who have coexisting cardio-respiratory disease e.g. ventricular dysfunction or history of AV Block /bradyarrythmias
- •Catheter removal unintentionally
- •Asymmetric or unilateral block requiring catheter manipulation
- •Patient not extubated and transferred to ICU
- •Surgery with blood loss more than 30%.
结局指标
主要结局
1. To compare the efficacy and duration of post operative epidural analgesia
时间窗: 48 hours
between the two groups using VAS score at rest and movement
时间窗: 48 hours
2. To compare cumulative consumption of rescue analgesia between the two groups
时间窗: 48 hours
次要结局
- To compare time to first rescue analgesia requirement between the two groups(48 hours)
- To compare incidence of such as bradycardia, hypotension and sedation,(post-operative ileus and nausea & vomiting between two groups)
研究者
Dr Aparna Sharma
Indira Gandhi Medical college, shimla