Evaluation of hemodynamic changes during laparoscopic cholecystectomy in patients with moderate to severe left ventricular dysfunction- A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of effect of pneumoperitoneum on CO and CI in patients with moderate to severe left ventricular dysfunction.
研究概览
简要总结
The present study shall be an open label cohort observational study. Patients with moderate to severe left ventricular dysfunction undergoing laparoscopic cholecystectomy shall be monitored with advance hemodynamic monitors like Flotrac and transthoracic echocardiography to study the effect of pneumoperitoneum on the hemodynamics. Consecutive ASA 1 patients shall also be studied for effect on hemodynamics following creation of pneumoperitoneum.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient planned for laproscopic cholecystectomy 2.Consent to participation 3.Age 18 to 65 years 4.Patient with echocardiography findings consistent with presence of moderate to severe left ventricular dysfunction for the study group.
排除标准
- •1.BMI >35kg/m2 2.Coexisting stenotic valve lesion or right ventricular dysfunction 3.presence of electrcardiographic finding of arrhythmia 4.NYHA 1V physical status 5.End stage hepatic/renal/pulmonary disease.
结局指标
主要结局
Evaluation of effect of pneumoperitoneum on CO and CI in patients with moderate to severe left ventricular dysfunction.
时间窗: All study parameters shall be recorded at the following time points. Pre-induction (T1), 10 minute after induction (T2), when pneumoperitoneum with intra-abdominal (IAP) pressure of 12mm Hg is achieved (T3), 10 minute after reverse Trendelenburg position(T4), 10 minute after deflation of pneumoperitoneum (T5).
次要结局
- Comparison of effect of pneumoperitoneum on hemodynamic parameters and cardiac function in patients with and without cardiac disease.(All study parameters shall be recorded at the following time points. Pre-induction (T1), 10 minute after induction (T2), when pneumoperitoneum with intra-abdominal (IAP) pressure of 12mm Hg is achieved (T3), 10 minute after reverse Trendelenburg position(T4), 10 minute after deflation of pneumoperitoneum (T5).)