NCT04826042

Brief Summary

One method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. There is no study whether equal volume of contrast medium injection has any increasing effect of optic nerve sheath diameter. This study is designed to measure the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

March 29, 2021

Last Update Submit

December 18, 2022

Conditions

Optic Nerve Sheath Diameter

Keywords

optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath change during 4 time period

    optic nerve sheath change during 4 time period using ultrasound

    Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention

Secondary Outcomes (1)

  • cerebral oxygenation change during 4 time period

    Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention

Study Arms (2)

contrast group

ACTIVE COMPARATOR

injection of contrast medium 6 cc during thoracic epidural catheterization

Other: thoracic epidural catheterization

normal saline group

PLACEBO COMPARATOR

injection of normal saline 6 cc during thoracic epidural catheterization

Other: thoracic epidural catheterization

Interventions

thoracic epidural catheterizationOTHER

thoracic epidural catheterization

contrast groupnormal saline group

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
  • gallbladder

You may not qualify if:

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

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, Park JH, Park KB. Comparison of Increase in the Optic Nerve Sheath Diameter between Epidural Saline and Contrast Medium Injections. Pain Physician. 2022 Mar;25(2):E263-E269.

    PMID: 35322981DERIVED

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

March 29, 2021

First Posted

April 1, 2021

Study Start

March 29, 2021

Primary Completion

August 29, 2022

Study Completion

August 29, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)