Evaluate the safety and efficacy of magnesium sulfate on hemodynamic respose to pneumoperitonium in patients undergoing laparoscopic surgeries.A placebo controlled single blind randomized study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Study the effect of magnesium sulfate on haemodynamic changes heart rate, systolic BP, diastolic BP, mean arterial pressure during laparoscopic surgeries.
研究概览
简要总结
Randomized prospective controlled comparative study to investigate the efficacy of magnesium sulfate Vs 0.9% saline in preventing adverse hemodynamic response associated with pneumoperitoeium in patients undergoing laparoscopic surgeries .
patients will be randomly allocated into 2 groups of 30 patients each. One group will receive magnesium sulfate 30mg/kg body weight IV before pneumoperitoneum and the other group will receive same volume of 0.9% saline. Values of heart rate , blood pressure , mean arterial pressure and oxygen saturation will be recorded before and after pneumoperitoneum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Eletive laparoscopic surgeries done under general anesthesia.
- •Patients between 18 to 60 years.
- •ASA grade I and II.
- •Patients giving consent for study.
排除标准
- •Patients not willing to participate in study Patients with hypermagnesemia.
- •Patients with morbid obesity, severe hepatic, renal, endocrine and cardiac dysfunction.
- •Pregnant and lactating patients.
结局指标
主要结局
Study the effect of magnesium sulfate on haemodynamic changes heart rate, systolic BP, diastolic BP, mean arterial pressure during laparoscopic surgeries.
时间窗: Study the effect of magnesium sulfate on haemodynamic changes heart rate, systolic BP, diastolic BP, mean arterial pressure in laparoscopic surgeries before pneumoperitoneum and every 15 minutes from pneumoperitoneum.
次要结局
- to assess the need for rescue drug(during surgery)
研究者
BINDIYA GAUTAM
DY PATIL UNIVERSITY SCHOOL OF MEDICINE NAVI MUMBAI