A Randomised Prospective Comparative study of different doses of Dexmeditomidine in attenuating in haemodynamic response to pneumoperitoneum and post operative recovery in patients undergoing laparoscopic surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in haemodynamic parameters- Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at intubation, during pneumoperitoneum and at extubation.
研究概览
简要总结
This is a Randomised Prospective comparative study to compare two different doses of Dexmeditomidine that is 0.6mcg per kg and 0.8mcg per kg intravenous as a premeditation to suppress the haemodynamic stress response to pneumoperitoneum and recovery profile in patients going elective laparoscopic surgeries under general anaesthesia.Total sample size is 90, divided into 3 groups including the control group.Primary objectives is to assess the changes in haemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at intubation, during pneumoperitoneum and at extubation. And also Cough reflex, Shivering and sedation score post operatively.Secondary objectives includes VAS score and first rescue analgesia post operatively and adverse events like Hypotension, Bradycardia, PONV.
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
- •All ASA grade 1 and 2 patients with BMI more than 18.5kg per meter square and less than 28kg per metre square, posted for elective laparoscopic surgery under general anaesthetia.
排除标准
- •Patients with ischemic heart disease, uncontrolled diabetes mellitus, asthma, COPD, uncontrolled hypertension,chronic renal disease and liver diseases.
- •Pregnant woman or lactating woman.
- •Patients with anticipated difficulty airway.
结局指标
主要结局
Changes in haemodynamic parameters- Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at intubation, during pneumoperitoneum and at extubation.
时间窗: Changes in haemodynamic parameters- HR,SBP,DBPand MAP at baseline,at the end of Dexmeditomidine infusion,1 and 5 min after intubation,before creating pneumoperitoneum,5,15,30,45,60,90 min after creating pneumoperitoneum, at the end of pneumoperitoneum and before extubation, after extubation, 5 min and 20 min after extubation. | Cough reflex, shivering and sedation score at extubation,20 min,2 hrs and 6hrs after extubation post operatively.
Cough reflex, shivering and sedation score post operatively.
时间窗: Changes in haemodynamic parameters- HR,SBP,DBPand MAP at baseline,at the end of Dexmeditomidine infusion,1 and 5 min after intubation,before creating pneumoperitoneum,5,15,30,45,60,90 min after creating pneumoperitoneum, at the end of pneumoperitoneum and before extubation, after extubation, 5 min and 20 min after extubation. | Cough reflex, shivering and sedation score at extubation,20 min,2 hrs and 6hrs after extubation post operatively.
次要结局
- VAS score and first rescue analgesia post operatively.(Adverse effects like Hypotension, bradycardia, PONV.)
研究者
Chaithra V P
Mysore medical college and research institute