A Randomized Comparative Study to Evaluate The Effects and Safety of Intrathecal Hyperbaric Levobupivacaine 0.5% and Hyperbaric Ropivacaine 0.75% In Patients Undergoing Transurethral Resection of Prostate(TURP) Surgery under Spinal Anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine.
研究概览
简要总结
The present prospective, randomized and double blind study will be conducted in Department of Anaesthesiology, MMIMSR Mullana Ambala, Haryana. After the approval of protocol by the Institutional Ethics Committee, and registration with Clinical Trial Registry India, a total number of 50 ASA I and ASA II status patients scheduled for elective TURP surgery under spinal anaesthesia will be included in the study after obtaining informed consent for the study. The effects and efficacy of hyperbaric LEVOBUPIVACAINE 0.5% and hyperbaric ROPIVACAINE 0.75% will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •ASA 1 and ASA 2 patients posted for TURP.
排除标准
- •Negative consent by the patient
- •Contraindication for spinal Anaesthesia (such as coagulopathy, infection at injection site, hypotension, disease or deformity of spine)
- •Psychiatric patient
- •ASA status III/IV
- •Known sensitivity to the drug.
结局指标
主要结局
The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine.
时间窗: Outcomes will be assessed at baseline, time intervals of 2min upto 10min after administration of spinal anaesthesia with the selected drugs followed by every 5 minutes until completion of surgery
次要结局
未报告次要终点
研究者
Karan Malhotra
MMIMSR, Mullana