CTRI/2023/06/054367尚未招募4 期
A comparative study of low dose Bupivacaine 0.5% (heavy), Levobupivacaine 0.5% (plain) and Levobupivacaine 0.5% (heavy) with Fentanyl as an adjuvant in Transurethral Resection of Prostate surgery: A prospective randomized study
Dr Sanyukta Paul1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年3月7日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Expected prolonged efficacy of Levobupivacaine 0.5% heavy over Bupivacaine 0.5% heavy & Levobupivacaine 0.5% plain
研究概览
简要总结
This is a prospective randomized study comparing low dose intrathecal Levobupicaine 0.5% heavy, Levobupivacaine 0.5% plain and Bupivacaine 0.5% heavy with Fentanyl as an adjuvant in Transurethral resection of prostate surgeries. In this study, we are comparing the onset and duration of motor block and sensory block, to study intraoperative hemodynamics and to study the untoward side effects,if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patient giving consent to participate in study Age between 50-75 years Weight between 45-70 kg ASA grade I and II Patient scheduled for TURP surgeries.
排除标准
- •Patients not giving consent to participate in the study.
- •Uncooperative patient ASA grade III and IV Patients with respiratory, cardiovascular, renal diseases, obesity.
- •Neurological disease (multiple sclerosis, symptomatic lumbar herniated disc, spinal stenosis) Coagulopathy Patient with known hypersensitivity to local anaesthetic.
- •Local sepsis or infection.
结局指标
主要结局
Expected prolonged efficacy of Levobupivacaine 0.5% heavy over Bupivacaine 0.5% heavy & Levobupivacaine 0.5% plain
时间窗: 24 hours
次要结局
- Expected lesser side effects & stable hemodynamic profile with Levobupivacaine 0.5% heavy than Bupivacaine 0.5% heavy and Levobupivacaine 0.5% plain(24 hours)
研究者
研究点 (1)
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