A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
This study has been completed.
Information provided by (Responsible Party):
First received: December 4, 2012
Last updated: August 16, 2016
Last verified: August 2016
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.
|Prostate Cancer||Drug: Total intravenous anesthesia Drug: Inhalation Anesthesia|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- Intraocular pressure [ Time Frame: 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)
|Study Start Date:||May 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Inhalational anesthesia group||
Drug: Inhalation Anesthesia
Anesthesia induction with intravenous propofol bolus of 1.5~2.5 mg/kg and remifentanil (effect site concentration 3 ng/mL)using target controlled infusion (TCI). Anesthesia maintenance with sevoflurane 1.5~2.0 % and remifentanil effect site concentration 2~5 ng/mL.
|Experimental: Total intravenous anesthesia group||
Drug: Total intravenous anesthesia
Anesthesia induction with intravenous propofol (effect site concentration 2.5 µg/mL) and remifentanil (effect site concentration 3 ng/mL) using target controlled infusion (TCI). Anesthesia maintenance with propofol effect site concentration 1.5~4 µg/mL and remifentanil effect site concentration 2~5 ng/mL.
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