- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03658057
Measurement of the Skin Sympathetic Nerve Activity
Recording Sympathetic Nerve Activity From the Skin During Surgery Under General Anesthesia : a Pilot Study
Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.
However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in anesthetized and/or paralyzed patients. Therefore, we planned this pilot study to observe whether the SKNA can be obtained in these patients. If the SKNA ca be observed, it will be presented in milivolt (uV).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway
Exclusion Criteria:
- Autonomic nervous system disease
- Medication acting on the autonomic nervous system
- Refuse to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: ROC
Neuromuscular blockade is performed in the ROC group by administering rocuronium 0.4~0.8mg/kg
before the insertion of laryngeal airway.
|
whether neuromuscular blockade by administering rocuronium is performed or not.
|
|
NO_INTERVENTION: Control
Neuromuscular blockade is not performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The skin sympathetic nerve activity presented as uV obtained via skin leads.
Time Frame: During surgery/anesthesia
|
A few studies reported that skin sympathetic nerve activity (SKNA) signal could be potentially observed by applying a high-pass filter of 500 Hz or a band-pass filter of 500~1000 Hz to electric signal from skin leads attached on the skin of the chest in awake volunteers.
However, it is not known if it would be also possible to observe the SKNA signal in anesthetized patients.
Also, there is no established method for quantitative or qualitative assessment of the SKNA signal.
|
During surgery/anesthesia
|
Collaborators and Investigators
Investigators
- Study Director: Yunseok Jeon, Jeon, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKNA pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.