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The Effect of Oxygen Administration on Regional Cerebral Oxygen Saturation (rSO2) in the Non-block Side After Stellate Ganglion Block

This study is currently recruiting participants.
Verified February 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01532713
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
SSNHL(Sudden Sensory Neural Hearing Loss)
 Procedure: oxygen administration

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • increase on the regional cerebral oxygen saturation [ Time Frame: 5 minutes after oxygen administration ] [ Designated as safety issue: No ]
    The rSO2 on the non-block side after SGB and additional oxygen administration will be compared with the baseline rSO2.


Estimated Enrollment: 41
Study Start Date: January 2012
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non-block side Procedure: oxygen administration
nasal O2 5L/min via nasal cannula

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532713

Contacts
Contact: Kyung Bong Yoon, Ph.D 82-2-2227-4193 KBYOON@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Do Hyung Kim     82-2-2228-2420     BREADFANS@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01532713     History of Changes
Other Study ID Numbers: 4-2011-0358
Study First Received: February 8, 2012
Last Updated: February 9, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Retrocochlear Diseases
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013