A comparative study of coloading efficacy of Ringers Lactate, 4% Balanced Succinyalted Gelatin Solution and 6% Hydroxyethyl Starch Solution in preventing hypotension following spinal anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Ringer Lactate is better overall including cost effectivenss than Gelatin and Hydroxyethyl Starch in prevention of post spinal hypotension
研究概览
简要总结
This randomized prospective study will be carried out on 90 adultpatients of ASA physical status I and II, scheduled for elective surgeriesunder spinal anaesthesia. After the approval by the institutional EthicalCommittee, written informed consent will be obtained from all the patientsbefore being included in the study. They will be randomly allocated tofollowing groups of 30 each:
• Group R: Patients will receive Ringer’s Lactate solution ascoloading fluid.
• Group G: Patientswill receive 4% Balanced Succinylated Gelatin solution as coloading fluid.
• Group H: Patientswill receive 6% Hydroxyethyl Starch solution as coloading fluid.
Patients in group-Rwill receive Ringer’s lactate, patients in group-G will receive 4%Balanced Succinylated Gelatin solution and group-H will receive 6%Hydroxyethyl Starch solution. All these solutions will be infused over aperiod of 20 minutes along with performance of subarachnoid block. Aftercoloading, all patients will receive Ringer’s Lactate solution for fluidmaintenance. Baseline parameters and post spinal parameters will be recordedusing an electronic patient monitoring device, and entered into each patientsproforma sheet. Following spinal anaesthesia mean arterial pressure will berecorded at following intervals -1,3,5,10,15,30,45,60,90 minutes and 3 hoursafter spinal anaesthesia.
The study will end atthe end of 1 month after all data has been obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Elective Surgeries under spinal anaesthesia.
排除标准
- •Patient allergic to any of colloids Patient with renal disease Patient Refusal Bleeding Diathesis Hemodynamically Unstable patients.
结局指标
主要结局
Ringer Lactate is better overall including cost effectivenss than Gelatin and Hydroxyethyl Starch in prevention of post spinal hypotension
时间窗: Base Line | Post Spinal | 1 Minute | 3 Minutes | 5 Minutes | 10 Minutes | 15 Minutes | 30 Minutes | 45 Minutes | 60 Minutes | 90 Minutes | 3 Hours
次要结局
- Ringer lactate is better overall including easy availibility and cost effective(Base Line)