NCT03152981

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

June 3, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

April 18, 2018

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

April 23, 2017

Last Update Submit

April 16, 2018

Conditions

Optic Nerve Sheath DiameterRobot Assisted Laparoscopic Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

  • Optic Nerve Sheath Diameter

    1 hour after Trendelenburg position

Study Arms (2)

Desflurane group

ACTIVE COMPARATOR

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: DesfluraneDrug: remifentanil

Propofol group

ACTIVE COMPARATOR

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: propofolDrug: remifentanil

Interventions

DesfluraneDRUG

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

Also known as: DES
Desflurane group
propofolDRUG

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

Also known as: PPF
Propofol group
remifentanilDRUG

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

Also known as: Remi
Desflurane groupPropofol group

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who did not agree to participate in the study
  • Patients with ophthalmic diseases
  • Patients with previous history of ophthalmic surgery
  • Patients with neurological disorders
  • Patients with history of head surgery due to neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

DesfluranePropofolRemifentanil

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eunsu Choi, Pf

    Seoul National Univ. Bundang Hospita

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2017

First Posted

May 15, 2017

Study Start

June 3, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

April 18, 2018

Record last verified: 2017-05

Locations

KR(1)