SSNHL(Sudden Sensory Neural Hearing Loss) Clinical Trial
| Verified date | March 2014 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | March 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | increase on the regional cerebral oxygen saturation | 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 | No |