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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total intravenous anesthesia
Inhalation Anesthesia
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Inhalational anesthesia group

    Total intravenous anesthesia group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Intraocular pressure
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2012
    Last Updated
    August 16, 2016
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01744262
    Brief Title
    A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inhalational anesthesia group
    Arm Type
    Active Comparator
    Arm Title
    Total intravenous anesthesia group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Total intravenous anesthesia
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Inhalation Anesthesia
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Intraocular pressure
    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)
    Time Frame
    Changes in intraocular pressure during pneumoperitoneum in the steep Trendelenburg position

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24500661
    Citation
    Yoo YC, Shin S, Choi EK, Kim CY, Choi YD, Bai SJ. Increase in intraocular pressure is less with propofol than with sevoflurane during laparoscopic surgery in the steep Trendelenburg position. Can J Anaesth. 2014 Apr;61(4):322-9. doi: 10.1007/s12630-014-0112-2. Epub 2014 Feb 4.
    Results Reference
    derived

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

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