Analysis of Change of Optic Nerve Sheath Diameter in Robot Assisted Laparoscopic Radical Prostatectomy

April 16, 2018 updated by: Seoul National University Hospital

Analysis of Change of Optic Nerve Sheath Diameter Using Ultrasonography in Robot Assisted Laparoscopic Radical Prostatectomy

In the present study, The investigators evaluated whether anesthetic agents effects on Optic Nerve Sheath Diameter in patients undergoing Robot Assisted Laparoscopic Radical Prostatectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National Univ. Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients undergoing robotic laparoscopic radical prostatectomy
  2. Adults 20 to 80 years of age
  3. American Society of Anesthesiologists Physical grade 1-2

Exclusion Criteria:

  1. Patients who did not agree to participate in the study
  2. Patients with ophthalmic diseases
  3. Patients with previous history of ophthalmic surgery
  4. Patients with neurological disorders
  5. Patients with history of head surgery due to neurological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desflurane group
In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure
Drug: Desflurane
In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
Other Names:
  • DES
Drug: remifentanil
In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
Other Names:
  • Remi
Active Comparator: Propofol group
In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
Drug: remifentanil
In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
Other Names:
  • Remi
Drug: propofol
In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
Other Names:
  • PPF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic Nerve Sheath Diameter
Time Frame: 1 hour after Trendelenburg position
1 hour after Trendelenburg position

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Eunsu Choi, Pf, Seoul National Univ. Bundang Hospita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1602/335-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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