20 Years
70 Years
Male
Prostate Cancer
Trial Information
Inclusion Criteria:
1. ASA class 1 or 2
2. Adults over the age of 20 and under 70
3. Patients undergoing robot-assisted laparoscopic radical prostatectomy
4. Patients that have given informed consent
Exclusion Criteria:
1. Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract,
retinal detachment)
2. Patients with history of ophthalmic surgery
3. Patients with high baseline intraocular pressure (over 30 mmHg)
4. Patients with active cardiac conditions (unstable angina, congestive heart failure)
5. Patients with uncontrolled hypertension (diastolic blood pressure > 110 mmHg)
6. Patients with history of allergic reactions to propofol
7. Illiterate patients
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Intraocular pressure
Outcome Description:
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)
Outcome Time Frame:
Changes in intraocular pressure during pneumoperitoneum in the steep Trendelenburg position
Safety Issue:
No
Authority:
Korea: Institutional Review Board
Study ID:
4-2011-0034
NCT ID:
NCT01744262
Start Date:
May 2011
Completion Date:
March 2012
Related Keywords:
- Prostate Cancer
- intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy
- Prostatic Neoplasms
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