- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532713
The Effect of Oxygen Administration on Regional Cerebral Oxygen Saturation (rSO2) in the Non-block Side After Stellate Ganglion Block
Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow in the non-block side. The investigators researched the effect of oxygen administration on rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.
The present study suggests that oxygen administration can increase the rSO2 of non-block side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with cerebral vascular disease during SGB.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages between 20 and 70 years
- ASA PS 1,2
- disease entity : pain in the head, neck, upper extremity, and SSNHL ( sudden sensory neural hearing loss )
Exclusion Criteria:
- patient with the tendency to bleed
- patient who had cerebrovascular disease
- patient with respiratory disease ( COPD: chronic obstructive lung disease )
- patients who do not give written informed consent to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: non-block side
|
nasal O2 5L/min via nasal cannula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
increase on the regional cerebral oxygen saturation
Time Frame: 5 minutes after oxygen administration
|
The rSO2 on the non-block side after SGB and additional oxygen administration will be compared with the baseline rSO2.
|
5 minutes after oxygen administration
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Park HM, Kim TW, Choi HG, Yoon KB, Yoon DM. The change in regional cerebral oxygen saturation after stellate ganglion block. Korean J Pain. 2010 Jun;23(2):142-6. doi: 10.3344/kjp.2010.23.2.142. Epub 2010 May 31.
- Kim EM, Yoon KB, Lee JH, Yoon DM, Kim DH. The effect of oxygen administration on regional cerebral oxygen saturation after stellate ganglion block on the non-blocked side. Pain Physician. 2013 Mar-Apr;16(2):117-24.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2011-0358
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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