CTRI/2023/03/051128尚未招募不适用
A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries
Kallepally Sannidhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to establish complete sensory and motor blockade
研究概览
简要总结
Title: A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries
Type of Study: A prospective single centre, observational study
Aim: To identify safer /more efficient adjuvant between fentanyl and buprenorphine
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients between 20 – 60 years of age, undergoing elective lower limb orthopaedic surgeries with American society of Anaesthesiologists (ASA) physical status 1 and 2.
排除标准
- •Patients with known allergy or hypersensitivity to local anaesthetic drugs Contraindications to regional or spinal anaesthesia BMI of less that 18.5 or more than 24.9 kg/m2 Patient not willing to give consent Emergencies, surgeries lasting >4 hours Patients in whom assessment of sensory and motor blockade is expected to be impossible/ unreliable.
结局指标
主要结局
Time to establish complete sensory and motor blockade
时间窗: Post spinal | 3 mins | 6 mins | 9 mins | 12 mins | 15 mins | 18 mins | 21 mins | Post surgery | 0 mins | 30 mins | 60 mins | 90 mins | 120 mins
Time for two segment regression and complete motor recovery
时间窗: Post spinal | 3 mins | 6 mins | 9 mins | 12 mins | 15 mins | 18 mins | 21 mins | Post surgery | 0 mins | 30 mins | 60 mins | 90 mins | 120 mins
次要结局
- Incidence of side effects- pruritis and urinary retention(Immediately in postop)
研究者
研究点 (1)
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