- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840995
The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter
January 26, 2015 updated by: Yonsei University
The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has the potential to cause an increase of intracranial pressure (ICP).
Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP.
Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who were scheduled to receive stellate ganglion block at our pain management clinic
Description
Inclusion Criteria:
- Adult patients (20-70 years of age)
- who were scheduled to receive stellate ganglion block at our pain management clinic
Exclusion Criteria:
- Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
- Patients with coagulation disorder
- Patients with severe obesity
- Patients with severe cardiovascular or pulmonary disease
- Patients with cognitive deficits or psychiatric illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
stellate ganglion block
Patients receiving stellate ganglion block at our pain management clinic
|
A thick layer of gel is applied on the upper closed eyelid.
The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye.
Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical.
The final ONSD is the mean of these measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ultrasonographic measurement of optic nerve sheath diameter
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 19, 2013
First Submitted That Met QC Criteria
April 23, 2013
First Posted (Estimate)
April 26, 2013
Study Record Updates
Last Update Posted (Estimate)
January 28, 2015
Last Update Submitted That Met QC Criteria
January 26, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4-2013-0078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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