A Study to Compare the Hemodynamic Changes in Patients Undergoing Cesarean Section under Spinal Anaesthesia When Pre-Loaded With Crystalloid vs. Colloid.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- This study will help us to know that which out of two intravenous solutions Colloid or Crystalloid is a better preloading solution to achieve the stable hemodynamics during cesarean section
研究概览
简要总结
A study to compare the hemodynamic changes in patients undergoing cesarean section under spinal anaesthesia when pre-loaded with crystalloid vs colloid
OBJECTIVES
1. To compare the efficacy of ringer lactate vs. HES (Hydroxyethyl Starch) as pre-loading agents in terms of hemodynamic response to spinal anaesthesia To
2. compare complications or side effects if any of both the fluids used for pre-loading.
Inclusion Criteria:
The patients belonging to ASA-I and ASA-II.
Age Group from 18 to 35 years.
Patients undergoing LSCS.
Duration of surgery from 2 to 2.5 hours
Exclusion Criteria:
All contraindications for spinal anaesthesia like: Patients refusal
Local infections
Spinal deformities
Bleeding disorder
Increased intracranial tension
Systolic blood pressure less than 100mmHg.
Age less than 18 years or more than 60 years.
Concomitant diseases like diabetes mellitus, hypertension, heart diseases, obesity.
Patients other than ASA I and ASA II.
**Study Site:**Dhiraj Hospital, S.B.K.S M.I.R.C. Piparia, Waghodia, Vadodara, Gujarat.
Study Design: Randomized, Prospective, Observational Study
Group A 35 patients receiving Inj. RL intravenously at the rate of 10ml/kg.
Group B 35 patients receiving Inj. Hydroxyethyl Starch intravenously at the rate of 10ml/kg.
Heart rate Systolic and diastolic blood pressure and mean arterial pressure will be monitored every 2 minutes for the first 10 minutes and then every 5 minutes till the next hour and then every 15 minutes till the end of surgery
STATASTICAL ANALYSIS:
We will find mean and standard deviation of all quantitative data and we will use parametric test like student T test (paired or unpaired), ANOVA (one way or repeated measure) to find statistical mean difference between variables. P value less than 0.05 will be considered as significance level.
Percentage will be used for qualitative data and non-parametric tests like chi square, Wilcoxon Rank test, Friedman test will be used to find significance level between variables and p value less than 0.05 will be considered as significance level
LIKELY OUTCOMES/ BENEFITS OF STUDY
This study will help us to know that which out of two intravenous solutions - Colloid or Crystalloid is a better preloading solution to achieve the stable hemodynamics during cesarean section.
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •The patients belonging to ASA-I and ASA-II.
- •Age Group from 18 to 35 years.
- •Patients undergoing LSCS.
- •Duration of surgery from 2 to 2.5 hours.
排除标准
- •A)All contraindications for spinal anaesthesia like: Patients refusal Local infections Spinal deformities Bleeding disorders Increased intracranial tension Systolic blood pressure less than 100mmHg. B)Age less than 18 years or more than 60 years.
- •C)Concomitant diseases – diabetes mellitus, hypertension, heart diseases, obesity.
- •D)Patients other than ASA-I and ASA-II.
结局指标
主要结局
This study will help us to know that which out of two intravenous solutions Colloid or Crystalloid is a better preloading solution to achieve the stable hemodynamics during cesarean section
时间窗: Heart rate ,Systolic and diastolic blood pressure and mean arterial pressure will be monitored every 2 minutes for the first 10 minutes and then every 5 minutes till the next hour and then every 15 minutes till the end of surgery
次要结局
- Requirement of vasopressor.Incidence of nausea and vomiting.Incidence if allergic reactions
研究者
Dr Vishwa Shah
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre