NCT03362255

Brief Summary

It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia. This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 13, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

November 28, 2017

Last Update Submit

July 1, 2018

Conditions

Optic Nerve Sheath Diameter

Keywords

Optic Nerve Sheath Diameter Injection Speed

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath diameter change among 4 time period

    optic nerve sheath diameter change among 4 time period using ultrasound

    Baseline, 1 minutes, 10 minutes, 30 minutes after the completion of the intervention

Study Arms (2)

Rapid speed of injection

ACTIVE COMPARATOR

Rapid speed of injection (3cc/sec) during thoracic epidurography thoracic epidural catheterization

Other: thoracic epidural catheterization

Slow speed of injection

ACTIVE COMPARATOR

Slow speed of injection (1cc/sec) during thoracic epidurography thoracic epidural catheterization

Other: thoracic epidural catheterization

Interventions

thoracic epidural catheterizationOTHER

thoracic epidural catheterization with different speed of injection

Rapid speed of injectionSlow speed of injection

Eligibility Criteria

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

You may qualify if:

  • lung cancer
  • liver cancer
  • stomach cancer
  • pancreas cancer

You may not qualify if:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level
  • previous brain surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Hee Hong

Daegu, 700712, South Korea

Location

Related Publications (1)

  • Hong JH, Jung SW, Park JH. The Effect of Speed of Normal Saline Injection on Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia. Pain Physician. 2019 Jul;22(4):E325-E332.

    PMID: 31337174DERIVED

Study Officials

  • Ji Hee Hong, PhD

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 5, 2017

Study Start

November 13, 2017

Primary Completion

May 5, 2018

Study Completion

May 5, 2018

Last Updated

July 3, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)