Comparison of the Effects of Sevoflurane and Desflurane Used for Anesthesia Maintenance on Optic Nerve Sheath Diameter in the Trendelenburg Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Optic Nerve Sheath Diameter (ONSD)
研究概览
简要总结
Laparoscopic surgeries require pneumoperitoneum and Trendelenburg position, which may lead to increased intracranial pressure (ICP).
Optic nerve sheath diameter (ONSD) measurement via ultrasound is a non-invasive method to evaluate ICP.
This prospective study aims to compare the effects of sevoflurane and desflurane on ONSD in patients undergoing laparoscopic hysterectomy and bilateral oophorectomy in the Trendelenburg position.
详细描述
The primary objective of this study is to compare the ONSD values measured by ultrasound between the sevoflurane and desflurane groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.
- •ASA physical status I-II
排除标准
- •Patients receiving beta-blocker or diuretic treatment.
- •Patients with severe heart failure.
- •Patients diagnosed with diabetes with ocular or neurological complications.
- •Patients who have undergone cardiac surgery, eye surgery, brain surgery, or thoracic surgery.
- •Patients with a history of hydrocephalus, glaucoma, intracranial mass, and stroke.
- •History of allergy to the study drugs
- •Known or suspected pregnancy
研究组 & 干预措施
Group 1 (Sevo)
Anaesthesia maintenance with sevoflurane titrated to 1.0 MAC in 40% oxygen / 60% air.
干预措施: Sevoflurane (Drug)
Group 2 (Des)
Anaesthesia maintenance with desflurane titrated to 1.0 MAC in 40% oxygen / 60% air.
干预措施: Desflurane (Drug)
结局指标
主要结局
Optic Nerve Sheath Diameter (ONSD)
时间窗: Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
Three measurements will be taken in the transverse and sagittal planes for each eye and the average will be calculated.
Optic Nerve Sheath Diameter (ONSD)
时间窗: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
ONSD measured by transorbital ultrasound with a 7.5-15 MHz linear probe, 3.0 mm behind the posterior globe wall, between the outer edges of the dural sheath. At least three measurements are obtained from each eye and averaged.
次要结局
- Heart Rate (HR)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
- Mean Arterial Pressure (MAP)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
- Peripheral Oxygen Saturation (SpO2)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
- End-tidal Carbon Dioxide (EtCO2)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
- Arterial pH(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
- Partial Pressure of Carbon Dioxide (pCO2)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
- Mean Arterial Pressure (MAP)(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- Peripheral Oxygen Saturation (SpO2)(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- End-tidal Carbon Dioxide (EtCO2)(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- Arterial pH(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- Partial Pressure of Carbon Dioxide (pCO2)(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- Change in optic nerve sheath diameter between consecutive study phases (Δ ONSD)(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- Arterial lactate(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
- Peak airway pressure(T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine)
研究者
Burak Omur
assistant professor
Medipol University