Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Effects of Pneumoperitoneum Pressure on ONSD Over Time
研究概览
简要总结
Purpose The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. The study will also evaluate whether these changes are related to symptoms such as headache, confusion, and nausea after surgery.
Study Design
This is a prospective, randomized, double-blind clinical trial. Patients undergoing elective laparoscopic cholecystectomy will be assigned to one of two groups:
Group 1: pneumoperitoneum at 8 mmHg Group 2: pneumoperitoneum at 14 mmHg ONSD will be measured at several time points before, during, and after surgery using transorbital ultrasonography.
详细描述
Purpose The aim of this clinical trial is to investigate how different intra-abdominal pressures applied during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which serves as a reliable, non-invasive marker of intracranial pressure. The study also seeks to determine whether perioperative ONSD changes are associated with postoperative symptoms such as headache, nausea, and disorientation, as well as with recovery parameters and hemodynamic stability.
Study Design
This is a prospective, randomized, double-blind, interventional clinical trial. Eligible patients scheduled for elective laparoscopic cholecystectomy will be randomized into two groups based on pneumoperitoneum pressure:
Group 1 (Low-pressure group): pneumoperitoneum maintained at 8 mmHg Group 2 (High-pressure group): pneumoperitoneum maintained at 14 mmHg
ONSD will be measured via transorbital ultrasonography at standardized perioperative time points:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •ASA physical status I-II
- •BMI < 30 kg/m²
- •Scheduled for elective laparoscopic cholecystectomy
排除标准
- •Known neurological diseases
- •Ocular pathology
- •History of elevated intracranial pressure (ICP)
- •Pregnancy
- •Need for emergency surgery
研究组 & 干预措施
8 mmHg pressure group
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 8 mmHg.
干预措施: 8 mmHg pressure group (Other)
14 mmHg pressure group
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.
干预措施: 14 mmHg pressure group (Other)
结局指标
主要结局
Effects of Pneumoperitoneum Pressure on ONSD Over Time
时间窗: T0: Before intubation T1: 30 minutes after the initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour after extubation T4: 2 hours after extubation
To compare the effect of two different pneumoperitoneum pressures (8 mmHg vs. 14 mmHg) on optic nerve sheath diameter (ONSD) during laparoscopic cholecystectomy. ONSD will be assessed by measuring changes with transorbital ultrasonography at multiple perioperative time points
次要结局
- Severity of postoperative headache assessed by Numerical Rating Scale (NRS, 0-10)(One hour after surgery)
- Number of participants with postoperative nausea assessed by a standardized 4-point nausea scale(One hour after surgery)
- Number of participants with postoperative vomiting within one hour after surgery(One hour after surgery)
研究者
Engin Çetin
principal investigator
Kocaeli City Hospital