COMPARATIVE STUDY OF INTRAVENOUSLY ADMINISTERED CLONIDINE AND MAGNESIUM SULPHATE IN ATTENUATING HEMODYNAMIC RESPONSE TO PNEUMOPERITONEUM DURING LAPAROSCOPIC CHOLECYSTECTOMY RANDOMISED BLINDED COMPARATIVE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Primary objective:
研究概览
简要总结
A randomized blinded comparative study will be conducted on 68 patients belonging to ASA I and II undergoing elective laparoscopic cholecystectomy. Patients of both gender ranging between 18 to 60 years of age will be included.
Our aim will be to evaluate and compare the effect of intravenously administered clonidine at 1.5 mcg/kg and magnesium sulphate at 50 mg/kg for attenuating the hemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy.
Patients will be divided randomly into two groups of 34 each. Group A will receive IV Inj. Clonidine 1.5 mcg/kg in 100 ml of NS over 10 mins and Group B will receive Inj. Magnesium sulphate 50 mg/kg in 100 ml of NS over 10 mins.
Randomization will be done by using a computer generated randomization table in blocks of four, and a ratio of 1:1 that placed patients into 2 groups equally.
The test drug solution will be given after intubation and before pneumoperitoneum creation. The heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, EtCO2, oxygen saturation, adverse effects and level of sedation will be assessed by Modified Ramsay sedation score in both groups.
The data collected will be analysed using IBM SPSS 22. Line diagram will be drawn for parameters like heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
The results will be obtained in the form of range, mean and standard deviation. t- test will be conducted for comparison of means. ANOVA test will be conducted.
The ‘p’ value of <0.05 will be considered statistically significant
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and ASA II Both gender in the agr group of 18-60 years Patients posted for elective laparoscopic cholecystectomy.
排除标准
- •Patients who refused to give informed written consent -Patients with known allergy to magnesium sulphate and clonidine.
- •Pregnant patients posted for lapascopic cholecystectomy.
结局指标
主要结局
Primary objective:
时间窗: 6 months
The aim of this study will be to compare the effect of IV administered Clonidine and Magnesium sulphate on hemodynamic response during pneumoperitoneum in laparoscopic cholecystectomy
时间窗: 6 months
次要结局
- comparison of adverse effects like hypotension, bradycardia(intra-operatively),nausea,vomiting,and shivering. Level of sedation immediately after extubation in both the groups will be assessed using Modified Ramsay Sedation Score(6 months)