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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03152981
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Analysis of Change of Optic Nerve Sheath Diameter Using Ultrasonography in Robot Assisted Laparoscopic Radical Prostatectomy
Actual Study Start Date :
Jun 3, 2017
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
Dec 30, 2017

Arms and Interventions

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: 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

    • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Optic Nerve Sheath Diameter [1 hour after Trendelenburg position]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National Univ. Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03152981
    Other Study ID Numbers:
    • B-1602/335-006
    First Posted:
    May 15, 2017
    Last Update Posted:
    Apr 18, 2018
    Last Verified:
    May 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Remifentanil
    Propofol
    Desflurane

    Study Results

    No Results Posted as of Apr 18, 2018