Comparison of fresh gas flow of anaesthesia and pneumoperitoneum on intracranial pressure as measured by optic nerve sheath diameter during laparoscopic cholecystectomy: a randomised clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To assess the change in ONSD at 30 minutes after pneumoperitoneum among patients undergoing laparoscopic cholecystectomy with varying flow and varying intraabdominal pressure.
研究概览
简要总结
This study is a prospective randomized controlled trial, primarily comparing the change in ONSD at different time intervals with varying flow and varying intraabdominal pressure in 112 patients undergoing laparoscopic cholecystectomy at AIIMS Gorakhpur. Secondary objectives will be to assess the change of hemodynamics(MAP, HR), change of ETCO2 and change of Peak airway pressure with pneumoperitoneum and flow of anaesthesia. In addition to this the correlation between post-operative nausea, vomiting and headache with change in ONSD will be assessed. Safety outcome will be recording and reporting of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group 18-65 years posted for elective surgery.
- •Belonging to ASA Grade I and II.
- •Patients willing to participate in the study.
排除标准
- •Patient unwilling to participate in the study.
- •Pregnant female.
- •Previous eye surgery.
- •Head and neck surgery.
- •Previous orbital trauma or surgical history.
- •Intracranial space covering lesions with high ICP.
- •Chronic kidney disease.
- •Cirrhosis with ascitis.
结局指标
主要结局
To assess the change in ONSD at 30 minutes after pneumoperitoneum among patients undergoing laparoscopic cholecystectomy with varying flow and varying intraabdominal pressure.
时间窗: 30 minutes after creation of pneumoperitoneum.
次要结局
- 1.To assess the change in ONSD at post induction, 15 mins after pneumoperitoneum in supine position and 10 mins after desufflation.(2.To assess the change in ONSD with low flow and normal flow anaesthesia.)
研究者
Dr Riya Rautela
AIIMS Gorakhpur