A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Intraocular pressure
研究概览
简要总结
Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the past decade and has widely replaced conventional open prostatectomy in many institutions due to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay. However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation, which leads to increased intraocular pressure (IOP). In particular, robot-assisted laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position and often prolonged insufflation times, which is known to effect the increase in IOP during surgery and may result in ophthalmic complications such as postoperative vision loss (POVL). The majority of patients undergoing RALRP is old aged and often present with comorbidities. Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having undiagnosed glaucoma is also increased, and therefore methods to prevent such complications are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous humour outflow to some extent. Among these agents, propofol has been reported to be more effective than other inhalational anesthetics in decreasing IOP. The goal of this prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide pneumoperitoneum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •ASA class 1 or 2
- •Adults over the age of 20 and under 70
- •Patients undergoing robot-assisted laparoscopic radical prostatectomy
- •Patients that have given informed consent
排除标准
- •Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract, retinal detachment)
- •Patients with history of ophthalmic surgery
- •Patients with high baseline intraocular pressure (over 30 mmHg)
- •Patients with active cardiac conditions (unstable angina, congestive heart failure)
- •Patients with uncontrolled hypertension (diastolic blood pressure > 110 mmHg)
- •Patients with history of allergic reactions to propofol
- •Illiterate patients
研究组 & 干预措施
Inhalational anesthesia group
干预措施: Inhalation Anesthesia (Drug)
Total intravenous anesthesia group
干预措施: Total intravenous anesthesia (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: Changes in intraocular pressure during pneumoperitoneum in the steep Trendelenburg position
Before induction of anesthesia (T0), 5 minutes after induction of anesthesia (T1), 5 minutes after pneumoperitoneum (T2), 30 minutes after steep Trendelenburg position with pneumoperitoneum (T3), 5 minutes after returning to horizontal position with pneumoperitoneum (T4), 5 minutes after desufflation (T5), 5 minutes after awakening in the operating room (T6), 60 minutes after awakening in the recovery room (T7), 24 hours after the operation (T9)
次要结局
未报告次要终点
