Effect of positive end-expiratory pressure on intracranial tension during laparoscopic gynecological surgeries. A Randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the effect of 5 cm and 8 cm of water positive end expiratory pressure (PEEP)
研究概览
简要总结
In laparoscopic gynecological surgery there is prolonged pneumoperitoneum and trendelenburg position (head down) over 30 degrees for surgical exposure. In patients undergoing laparoscopic surgeries under anesthesia, there is a triple compartment involvement, increased intra-abdominal pressures due to pneumoperitoneum, increased intra thoracic pressures due to intermittent positive pressure ventilation (IPPV) results in an increased intra cranial pressure. Many studies have suggested an increased PEEP to improve lung function, however the dangers of increasing PEEP on the intra cranial pressures, have not been studied especially in gynaecological laparoscopic surgeries, where steep head down position is given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient aged 18-60 years, ASA 1 and 2 scheduled for laparoscopic gynecological surgeries.
排除标准
- •Patient aged less than 18 and more 60 years, ASA 3 and 4, patient refusal for study, patient having previous history and ongoing ocular disease or taking medication for ocular disease, patients with neurological disease and transient ischemic attack, patient who had elevated IOP or ICP, patient who are converted to open surgery.
结局指标
主要结局
To compare the effect of 5 cm and 8 cm of water positive end expiratory pressure (PEEP)
时间窗: Optic Nerve Sheath Diameter: T0-5 minutes after induction of general anesthesia. | T1-10 minutes after patient is placed in pneumoperitoneum and change in position. | T2-30 minutes after pneumoperitoneum | T3-5 minutes after desufflation once patient had become supine.
versus Zero PEEP (ZEEP) application on the optic nerve sheath diameter.
时间窗: Optic Nerve Sheath Diameter: T0-5 minutes after induction of general anesthesia. | T1-10 minutes after patient is placed in pneumoperitoneum and change in position. | T2-30 minutes after pneumoperitoneum | T3-5 minutes after desufflation once patient had become supine.
次要结局
- To compare the changes in optic disc elevation with PEEP of 0 cm, 5 cm and 8 cm water.(from 5 minutes after induction of general anesthesia to 5 minutes after desufflation once patient had become supine.)
研究者
Vaibhav Sonker Shastri
AIIMS PATNA