The Effect of Dexmedetomidine in 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
- 70
- 主要终点
- Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy.
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 timeds of pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in intraocular pressure during roboti-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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA class I-II
- •obtaining written informed consent from the parents
- •aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy
排除标准
- •eye surgery prevoiusly
- •unstable angina or congestive heart failure
- •concomittant eye disease (glaucoma, diabetic retinophaty, cataract, retinal detachment)
- •high intraocular pressure over 30mmHg after screening test.
- •uncontrolled hypertension (diastolic bp>110mmHg)
- •bradycardia under 60bpm
- •Ventricular conduction abnormality
- •hepatic failure
- •renal failure
- •drug hyperactivity
- •neurological or psychiatric illnesses
- •mental retardation
- •patients who can't read the consent form due to illiterate or foreigner
研究组 & 干预措施
dexmedetomidine
dexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position
干预措施: Dexmedetomidine (Drug)
saline
Saline infusion from same time period.
干预措施: saline (Drug)
结局指标
主要结局
Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy.
时间窗: change of intraocular pressure from T0 to T11 for 60mins
T0: Pre-induciton T1: 5min after anesthesia induction T2: 5 min after establish pneumoperitoneum T3: 15min after steep trendelenburg position T4: 30min after steep trendelenburg position T5: 45min after steep trendelenburg T6: 60min after steep trendelenburg T7: 75min after steep trendelenburg T8: 5min after returning to horizontal position T9: operation end T10: 5min after tracheal extubation T11: 60min after tracheal extubation
次要结局
未报告次要终点