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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01744262
First received: December 4, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Total intravenous anesthesia
Drug: Inhalation Anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 66
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01744262     History of Changes
Other Study ID Numbers: 4-2011-0034
Study First Received: December 4, 2012
Last Updated: February 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014