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The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter

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ClinicalTrials.gov Identifier: NCT01840995
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date April 19, 2013
First Posted Date April 26, 2013
Last Update Posted Date January 28, 2015
Study Start Date April 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2013)
ultrasonographic measurement of optic nerve sheath diameter [ Time Frame: 15 minutes ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01840995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter
Official Title Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who were scheduled to receive stellate ganglion block at our pain management clinic
Condition
  • Pain
  • Intracranial Pressure
Intervention Procedure: ultrasonographic measurement of optic nerve sheath diameter
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.
Study Groups/Cohorts stellate ganglion block
Patients receiving stellate ganglion block at our pain management clinic
Intervention: Procedure: ultrasonographic measurement of optic nerve sheath diameter
Publications * Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2013)
35
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840995
Other Study ID Numbers 4-2013-0078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date January 2015