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Clinical Trials/NCT01744262
NCT01744262
Completed
Not Applicable

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

Yonsei University0 sites66 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Inhalation Anesthesia
Conditions
Prostate Cancer
Sponsor
Yonsei University
Enrollment
66
Primary Endpoint
Intraocular pressure
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
March 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ASA class 1 or 2
  • Adults over the age of 20 and under 70
  • Patients undergoing robot-assisted laparoscopic radical prostatectomy
  • Patients that have given informed consent

Exclusion Criteria

  • Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract, retinal detachment)
  • Patients with history of ophthalmic surgery
  • Patients with high baseline intraocular pressure (over 30 mmHg)
  • Patients with active cardiac conditions (unstable angina, congestive heart failure)
  • Patients with uncontrolled hypertension (diastolic blood pressure \> 110 mmHg)
  • Patients with history of allergic reactions to propofol
  • Illiterate patients

Arms & Interventions

Inhalational anesthesia group

Intervention: Inhalation Anesthesia

Total intravenous anesthesia group

Intervention: Total intravenous anesthesia

Outcomes

Primary Outcomes

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)

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