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

Primary Purpose

SSNHL(Sudden Sensory Neural Hearing Loss)

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

oxygen administration

About this trial

This is an interventional prevention trial for SSNHL(Sudden Sensory Neural Hearing Loss)

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

non-block side

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01532713

First Posted

February 8, 2012

Last Updated

March 4, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01532713

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SSNHL(Sudden Sensory Neural Hearing Loss)

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

non-block side

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

oxygen administration

Intervention Description

nasal O2 5L/min via nasal cannula

Primary Outcome Measure Information:

Title

increase on the regional cerebral oxygen saturation

Description

The rSO2 on the non-block side after SGB and additional oxygen administration will be compared with the baseline rSO2.

Time Frame

5 minutes after oxygen administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

20556217

Citation

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.

Results Reference

background

PubMed Identifier

23511678

Citation

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.

Results Reference

derived

Learn more about this trial

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

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