Effect of Intrathecal Injection of 0.5 PERCENTAGE Hyperbaric Levobupivacaine Versus a Combination of 0.5 PERCENTAGE Hyperbaric and 0.5 PERCENTAGE Isobaric Levobupivacaine on Post-Spinal Hypotension and Block Characteristics in Patients Undergoing Lower Abdominal Surgery- A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Primary objective:
研究概览
简要总结
Effect of intrathecal Injection of 0.5 % hyperbaric levobupivacaine versus a combination of 0.5% hyperbaric and 0.5% isobaric levobupivacaine on post spinal hypotension and block characteristics in lower abdomen surgery – A Double blinded Randomized Control Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •1.Patients undergoing lower abdominal surgery under spinal anaesthesia of either gender 2.Age 18 – 70 years 3.American Society of Anesthesiologists classification I – II.
排除标准
- •1.contraindications for neuraxial anesthesia include local sepsis, coagulopathy, increased intracranial pressure, and spinal deformity 2.Patients having Heart rate <50bpm 3.Patients allergic to study drugs 4.Severe valvular stenotic lesion sepsis, 5.Patients with preexisting Neurological or neuromuscular diseases,Pregnant women.
结局指标
主要结局
Primary objective:
时间窗: Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery
To compare the incidence of post-spinal hypotension in patients receiving intrathecal 0.5 %
时间窗: Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery
hyperbaric levobupivacaine versus the combination of intrathecal 0.5% hyperbaric and 0.5%
时间窗: Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery
isobaric levobupivacaine in patients undergoing lower abdominal surgery under spinal
时间窗: Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery
anesthesia.
时间窗: Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery
次要结局
- 1. To assess other hemodynamic parameters (HR, SBP, DBP, MAP) between both groups(at different time intervals)
研究者
DR PRIYADHARSHINI S
Pondicherry Institute of Medical Sciences