The Effects of Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Gyneco-oncologic Surgeries
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
- 2
- 主要终点
- Measurement of optic nerve sheath diameter (ONSD)
研究概览
简要总结
The aim of this study is to investigate the effects of low and normal intraperitoneal pressures on intraoperative optic nerve sheath diameter in laparoscopic gyneco-oncologic surgeries.
详细描述
Gynecological surgeries are minimally invasive procedures. The establishment of pneumoperitoneum, special patient positioning, and surgical stimulation can induce a stress response in patients. Carbon dioxide (CO₂) pneumoperitoneum and the Trendelenburg position lead to increases in intra-abdominal, intrathoracic, and airway pressures, which in turn may directly or indirectly cause elevations in intracranial and intraocular pressures.
During the perioperative period, the optic nerve sheath diameter (ONSD), measured ultrasonographically, is used as a reliable method to estimate intracranial pressure (ICP). Monitoring ICP under anesthesia may help prevent neurological complications such as neurological deterioration and optic neuropathy. Furthermore, studies have demonstrated ICP changes in robotic and laparoscopic gynecologic surgeries through ultrasonographic measurement of ONSD.
Traditionally, laparoscopic abdominal surgeries are performed using intraperitoneal pressures ranging between 10 and 18 mmHg. Lower intra-abdominal pressures have been associated with reduced postoperative pain, improved pulmonary parameters, and a decreased risk of gas embolism. However, the data on these outcomes remain limited.
In this study, we aimed to investigate the effect of pressures above and below 12 mmHg on the optic nerve sheath diameter-and consequently on intracranial pressure-in patients undergoing laparoscopic gynecologic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The investigator will be blinded to whether low or intraperitoneal pressure is applied to the patients.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Laparoscopic gyneco-oncological surgeries
- •Female patients aged 18-65 years
- •ASA physical status classification I-II-III patients
排除标准
- •Patients with diabetic retinopathy
- •Patients with glaucoma
- •Patients with cerebrovascular disease
- •Pregnant women
- •Patients with known allergy to anaesthetic agents
- •Morbidly obese patients with BMI > 40
研究组 & 干预措施
Low Pressure Group
In laparoscopic gyneco-oncological surgeries, low pressure group received below 12 mmHg intraperitoneal pressure.
干预措施: Low pressure group (Other)
Normal Pressure Group
In laparoscopic gyneco-oncological surgeries, normal pressure group received 12 and abowe 12 mmHg intraperitoneal pressure.
干预措施: Normal pressure group (Other)
结局指标
主要结局
Measurement of optic nerve sheath diameter (ONSD)
时间窗: 30 minutes after introducing pneumoperitoneum and position change
ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measurement of optic nerve sheath diameter (ONSD)
时间窗: 30 minutes after introducing pneumoperitoneum and position change
ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
次要结局
- Measurement of optic nerve sheath diameter (ONSD)(The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.)
- Measurement of optic nerve sheath diameter (ONSD)(The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.)
- Measurement of optic nerve sheath diameter (ONSD)(The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation)
- Measurement of optic nerve sheath diameter (ONSD)(5 minutes after introducing pneumoperitoneum and position change)
- Measurement of optic nerve sheath diameter (ONSD)(60 minutes after introducing pneumoperitoneum and position change)
- Measurement of optic nerve sheath diameter (ONSD)(90 minutes after introducing pneumoperitoneum and position change)
研究者
Zeynep Koc
principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital