The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
研究概览
简要总结
Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •ASA class I-II
- •obtaining written informed consent from the parents
- •aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy
排除标准
- •eye surgery previously
- •unstable angina or congestive heart failure
- •concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
- •high intraocular pressure over 30mmHg after screening test.
- •uncontrolled hypertension (diastolic bp>110mmHg)
- •coagulopathy
- •hepatic failure
- •renal failure(creatinine clearance < 30 ml/min)
- •drug hyperactivity
- •neurological or psychiatric illnesses
- •mental retardation
- •patients who can't read the consent form due to illiterate or foreigner
- •previous malignant hyperthermia Hx
- •drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)
- •BMI > 30kg/m2
研究组 & 干预措施
Deep neuromuscular blockade
Deep neuromuscular blockade
干预措施: deep neuromuscular blockade (Procedure)
Deep neuromuscular blockade
Deep neuromuscular blockade
干预措施: Rocuronium (Drug)
Deep neuromuscular blockade
Deep neuromuscular blockade
干预措施: Sugammadex (Drug)
moderate neuromuscular blockade
moderate neuromuscular blockade
干预措施: Neostigmine (Drug)
moderate neuromuscular blockade
moderate neuromuscular blockade
干预措施: moderate neuromuscular blockade (Procedure)
moderate neuromuscular blockade
moderate neuromuscular blockade
干预措施: Atracurium (Drug)
结局指标
主要结局
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
时间窗: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position
maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
次要结局
- Overall Surgical Condition(At the end of the Steep trendelenburg position, an average of 1 hour)