Optic Nerve Sheath Diameter Difference Between Different Injection Volume
Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter
1 other identifier
interventional
50
1 country
1
Brief Summary
Valid method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. Different volume of injection is known to affect the degree of increase of intracranial pressure. This study is desinged to measure the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2020
CompletedFirst Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2020
CompletedNovember 18, 2020
November 1, 2020
6 months
May 28, 2020
November 16, 2020
Conditions
Keywords
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 (3)
injection of low volume of saline
ACTIVE COMPARATORlow volume (5 cc) saline injection during thoracic epidural catheterization
injection of intermediate volume of saline
ACTIVE COMPARATORintermediate volume (10 cc) saline injection during thoracic epidural catheterization
injection of high volume of saline
ACTIVE COMPARATORhigh volume (20 cc) saline injection during thoracic epidural catheterization
Interventions
thoracic epidural catheterization for postoperative pain control
Eligibility Criteria
You may qualify if:
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
- gallbladder cancer
You may not qualify if:
- coagulopathy
- infection
- previous spine fusion at thoracic level
- previous brain lesion causing increased intracranial pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hong ji HEE
Daegu, 42601, South Korea
Related Publications (1)
Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013.
PMID: 34704711DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Hee Hong, PhD
Keimyung University
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
May 28, 2020
First Posted
June 2, 2020
Study Start
May 25, 2020
Primary Completion
November 16, 2020
Study Completion
November 16, 2020
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share