Volatile Versus Total Intravenous Anesthesia and Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Change in Optic Nerve Sheath Diameter During the Perioperative Period
研究概览
简要总结
This study compared two commonly used general anesthesia techniques in adults undergoing elective laparoscopic gallbladder surgery. One group received total intravenous anesthesia (TIVA) with propofol, while the other group received volatile induction and maintenance anesthesia (VIMA) with sevoflurane.
The main purpose of the study was to compare changes in optic nerve sheath diameter, measured noninvasively by ultrasound, because this measurement can reflect changes in pressure inside the skull. Measurements were taken at several time points before, during, and after surgery. The study also compared blood pressure, heart rate, oxygen levels, depth of anesthesia, breathing-related measurements, postoperative pain, nausea, vomiting, headache, recovery time, and anesthetic drug cost between the two groups.
Adult patients aged 18 to 80 years with ASA physical status I-II who were scheduled for elective laparoscopic cholecystectomy were included. The study was conducted at Istanbul Bağcılar Training and Research Hospital.
详细描述
This prospective, single-center, randomized, open-label study compared total intravenous anesthesia (TIVA) with volatile induction and maintenance anesthesia (VIMA) in adult patients undergoing elective laparoscopic cholecystectomy. The primary objective was to evaluate whether the anesthetic technique influenced perioperative changes in optic nerve sheath diameter (ONSD), a noninvasive ultrasonographic surrogate marker of intracranial pressure.
ONSD was measured from the right eye using a 12-MHz linear ultrasound probe at six predefined perioperative time points: before induction, after tracheal intubation, after pneumoperitoneum, after reverse Trendelenburg positioning, 30 minutes after intubation, and after desufflation. Six consecutive measurements were obtained at each time point and averaged. Pneumoperitoneum pressure was maintained at 12 mmHg, reverse Trendelenburg positioning was 15°-30°, and anesthetic depth was guided by Bispectral Index monitoring.
Secondary assessments included intraoperative hemodynamic and respiratory variables, postoperative pain, nausea, vomiting, headache, diplopia, recovery time, and anesthetic drug cost. The final analysis was performed on the evaluable per-protocol population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective laparoscopic cholecystectomy
- •Provided written informed consent to participate
排除标准
- •Refusal to participate
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus
- •History of malignancy
- •Severe cardiovascular disease, including congestive heart failure or myocardial infarction
- •Severe cerebrovascular disease, including previous stroke
- •Hepatic dysfunction
- •Renal dysfunction
- •Pregnancy or lactation
- •Intracranial space-occupying lesion or any condition predisposing to increased intracranial pressure
- •Known optic nerve pathology
结局指标
主要结局
Change in Optic Nerve Sheath Diameter During the Perioperative Period
时间窗: From before induction of anesthesia to 5 minutes after desufflation
Optic nerve sheath diameter (ONSD) was measured ultrasonographically in the right eye using a 12-MHz linear probe, 3 mm posterior to the point at which the optic nerve enters the globe. Six consecutive measurements were obtained at each time point and averaged. The perioperative ONSD profile was compared between the TIVA and VIMA groups.
次要结局
- Systolic Arterial Pressure(From before induction of anesthesia to 5 minutes after desufflation)
- Change in Peripheral Oxygen Saturation(From before induction of anesthesia to 5 minutes after desufflation)
- Change in Bispectral Index(From before induction of anesthesia to 5 minutes after desufflation)
- Anesthetic Drug Cost(From induction of anesthesia to completion of anesthesia)
- Diastolic Arterial Pressure(From before induction of anesthesia to 5 minutes after desufflation)
- Mean Arterial Pressure(From before induction of anesthesia to 5 minutes after desufflation)
- Heart Rate(From before induction of anesthesia to 5 minutes after desufflation)
研究者
Serdar Demirgan
Associate proffesor
Bagcilar Training and Research Hospital