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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03658057
Other study ID # SKNA pilot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2018
Est. completion date November 1, 2018

Study information

Verified date February 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer Surgery

Intervention

Drug:
Rocuronium
whether neuromuscular blockade by administering rocuronium is performed or not.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The skin sympathetic nerve activity presented as uV obtained via skin leads. 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