Measurement of the Skin Sympathetic Nerve Activity

NCT03658057 | Completed

• 1 other identifier: SKNA pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ROC

ACTIVE COMPARATOR

Neuromuscular blockade is performed in the ROC group by administering rocuronium 0.4\~0.8mg/kg before the insertion of laryngeal airway.

Drug: Rocuronium

Control

NO INTERVENTION

Neuromuscular blockade is not performed.

Interventions

Rocuronium DRUG

whether neuromuscular blockade by administering rocuronium is performed or not.

ROC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway

You may not qualify if:

• Autonomic nervous system disease
• Medication acting on the autonomic nervous system
• Refuse to participate

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yunseok Jeon, Jeon

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: August 31, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

KR (1)