Effect of low versus standard pressure pneumoperitoneum on intracranial pressure using ultrasound assisted Optic nerve sheath diameter in laparoscopic cholecystectomy under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- OPTIC NERVE SHEATH DIAMETER:- Measured through ultrasound assistance in both eyes. Primary goal is to compare the impact of Low versus Standard pressure pneumoperitoneum on Intracranial pressure using ultrasound assisted Optic nerve sheath diameter in patients undergoing elective laparoscopic cholecystectomy
研究概览
简要总结
Optic nerve sheath diameter measurement is an indirect measurement of Intracranial pressure and can give us information about the intracranial pressure changes during laparoscopic surgery. Optic nerve sheath diameter using ultrasound is a relatively newer modality. Various pressures of pneumoperitoneum can have varied effects on haemodynamic parameters and we are going to compare the effects between two groups through our study. This will be a comparative, double blinded study which will be conducted in Guru Nanak Dev Hospital, Amritsar after taking informed consent in patient’s vernacular language. This study will be conducted on 100 patients aged 18-65 years of either sex, of ASA grade I-II, scheduled to undergo elective laparoscopic cholecystectomy surgery under general anaesthesia. Optic nerve sheath diameter measurements will be done with the help of ultrasound machine high frequency linear probe at different time intervals in both eyes during the course of surgery and we will try to find relation between set pneumoperitoneum pressures and its effect on optic nerve sheath diameter at various time intervals. Other haemodynamic parameters will be measured accordingly. The data thus obtained will be analyzed and compared statistically.
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 65.00 Year(s)（—）
入选标准
- •1.Age 18-65 years 2.Gender (both males and females) 3.American Society of Anaesthesiologists (ASA) Grade I-II 4.Elective laparoscopic cholecystectomy surgery under general anaesthesia 5.Duration of surgery less than 2 hours.
排除标准
- •1.Patients not willing to take part in study and refusing for consent 2.Patients with ASA Grade III and IV 3.Patients with Mallampatti grading III and IV or difficult airway 4.Patients with prior history of orbital trauma 5.Past history of neurological diseases 6.Patients with history of glaucoma 7.Surgical duration beyond 2 hours 8.Known history of Chronic Obstructive Pulmonary Disease (COPD) 9.History of heart disease 10.Previous lung surgery 11.Patients who will have intraoperative haemodynamic instability 12.Patients who will require conversion to open cholecystectomy procedure intraoperatively 13.Patients with etco2 value greater than 45 mmhg,plateau pressure above 30 cm h20 will be excluded from our study.
结局指标
主要结局
OPTIC NERVE SHEATH DIAMETER:- Measured through ultrasound assistance in both eyes. Primary goal is to compare the impact of Low versus Standard pressure pneumoperitoneum on Intracranial pressure using ultrasound assisted Optic nerve sheath diameter in patients undergoing elective laparoscopic cholecystectomy
时间窗: Optic nerve sheath diameter will be measured at following time intervals:- | 1.Before Induction of Anaesthesia | 2.5 minutes after induction in supine position | 3.10 minutes post pneumoperitoneum | 4.10 minutes after 30-degree reverse Trendelenberg positioning | 5.At every 20 minutes interval intraoperatively | 6.After returning to supine position without pneumoperitoneum
次要结局
- 1.Haemodynamic changes:- Comparison of vital signs (Heart rate, Mean Arterial pressure) between the two groups at low versus standard pressure pneumoperitoneum(2.To observe Complications, if any)
研究者
Dr Ranjana Khetarpal
Government Medical College, Amritsar