A prospective study to evaluate and compare the optic nerve sheath diameter (ONSD) assessed by ultrasound following tracheal intubation or insertion of I-Gel in patients undergoing laparoscopic cholecystectomy under general anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in ONSD
研究概览
简要总结
Laparoscopic cholecystectomy is the gold standard for gallstone and gallbladder diseases. After pneumoperitoneum, changes maybe observed in intrathoracic, intraabdominal, intracranial pressures. To measure intracranial pressure technique like orbital sonography with optic nerve sheath diameter measurement has been developed. This trial is ’evaluation and comparison of the Optic Nerve Sheath Diameter (ONSD) assessed by ultrasound following tracheal intubation or insertion of I-Gel’. We will include the patients aged from 25 to 60 years of either sex with gall stone disease undergoing laparoscopic cholecystectomy under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients between the age group 25 to 60 years
- •ASA class 1-2
- •BMI 18.5-29.9 kg/m2
- •Mallampati 1 or 2.
排除标准
- •Patients with Severe Cardiovascular or Respiratory disorders, Diabetes, Hypertension
- •Obesity (BMI>30kg/m2)
- •Difficult airway
- •History of sleep apnea
- •Eye surgery, Orbital trauma
- •Anticipated duration of surgery >2 hours.
结局指标
主要结局
Changes in ONSD
时间窗: T0- before induction of anesthesia, T1- 5 min after intubation/Igel insertion in supine position, T2- 10 min post pneumoperitoneum, T3- 10 min after 30 degree reverse Trendelenburg positioning, T4- pneumoperitoneum and reverse Trendelenburg, T5- 5 min after supine position without pneumoperitoneum
次要结局
- postoperative nausea and vomiting(24 hours after surgery)
- Heart Rate, Mean arterial blood pressure, Peak airway pressure, EtCO2(as in primary outcome)