drugset / Trial / NCT01744262

A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

NCT01744262 ↗

Completed 66 enrolled Yonsei University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2011-05
Primary completion
2012-03
Completion
2012-03

Outcome

Met primary endpoint

paper This increase is less with propofol than with sevoflurane anesthesia. PMID 24500661 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sevoflurane Other / unclassified 1.5 % Inhaled
Comparator Sevoflurane Other / unclassified 2 % Inhaled
Subject Total intravenous anesthesia Unknown 1.5 ug/ml Intravenous
Subject Total intravenous anesthesia Unknown 4 ug/ml Intravenous
Subject Total intravenous anesthesia Unknown 1.5 mg/kg Intravenous
Subject Total intravenous anesthesia Unknown 2.5 mg/kg Intravenous
Background Remifentanil Small molecule 2 ng/ml Intravenous
Background Remifentanil Small molecule 5 ng/ml Intravenous

Indications