Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer SurgeryNCT03658057
Measurement of the Skin Sympathetic Nerve Activity
A study testing Rocuronium in people with Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer Surgery
- What is being tested?
- Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway
Who cannot join
- Autonomic nervous system disease
- Medication acting on the autonomic nervous system
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
whether neuromuscular blockade by administering rocuronium is performed or not.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rocuronium |
| Control | No intervention | Neuromuscular blockade is not performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery/anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start31 Aug 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, Jeon, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658057
- Sponsor's protocol ID
- SKNA pilot
- Status last verified
- Feb 2019
- First submitted
- 29 Aug 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording Sympathetic Nerve Activity From the Skin During Surgery Under General Anesthesia : a Pilot Study
- ClinicalTrials.gov ID
- NCT03658057
- Acronym / sponsor ID
- SKNA pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROC | Active comparator | Drug: RocuroniumNeuromuscular blockade is performed in the ROC group by administering rocuronium 0.4~0.8mg/kg before the insertion of laryngeal airway. |
| Control | No intervention | –Neuromuscular blockade is not performed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway
Key exclusion criteria (3 listed)
- Autonomic nervous system disease
- Medication acting on the autonomic nervous system
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuroniumwhether neuromuscular blockade by administering rocuronium is performed or not. | Drug | ROC |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunseok Jeon, Jeon study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium in people with Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer Surgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The skin sympathetic nerve activity presented as uV obtained via skin leads. (time frame: During surgery/anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.