SKNA According to Different AnestheticsNCT03763305
Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics
A study testing Propofol continuous infusion, Remifentanil and Sevoflurane in people with SKNA According to Different Anesthetics, run by Seoul National University Hospital.
Trial summary
Skin sympathetic nerve activity (SKNA) has recently been discovered from the electrocardiogram obtained from healthy volunteers. The raw physiologic electric signal from electrodes placed on the skin was reprocessed through filtering and integration using software to produce the SKNA signal. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- SKNA According to Different Anesthetics
- What is being tested?
- Propofol continuous infusion, Remifentanil and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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
- Scheduled to undergo elective transurethral procedures under general anesthesia
Who cannot join
- Diagnosed with autonomic dysfunction
- Current use of beta blockers
- Cardiac arrhythmia
- Absolute indication for either TIVA or inhalants, absolute contraindication for either TIVA or inhalants (adverse effects on either propofol or remifentanil, risk of malignant hyperthermia)
About this study
Official title: Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics During Transurethral Procedures
Skin sympathetic nerve activity (SKNA) has recently been discovered from the electrocardiogram obtained from healthy volunteers. The raw physiologic electric signal from electrodes placed on the skin was reprocessed through filtering and integration using software to produce the SKNA signal. However, no study has yet provided knowledge on the effect of anesthetics on SKNA during general anesthesia.
Read the detailed description
The most commonly used anesthetic techniques during general anesthesia are the total intravenous anesthesia (TIVA) and anesthesia using inhalants such as sevoflurane or desflurane. For TIVA, the combination of propofol and remifentanil has been used and remifentanil is known for increasing vagal tone and inhibiting sympathetic nervous system as other opioids do. Sevoflurane is presumed to have no effect on parasympathetic or sympathetic tone. On the other hand, desflurane induces tachycardia and is noted for activating sympathetic activity. Previous studies on sympathetic nervous activity according to different anesthetics did not directly measure sympathetic tone but have relied on indirect measures such as blood pressure, heart rate, and heart rate variability.
In order to evaluate skin sympathetic nerve activity according to different anesthetics, we will be recruiting patients undergoing transurethral procedures, where the sympathetic tone is expected to be activated during anesthesia and surgery. The transurethral procedures consist of transurethral resection of bladder (TURB) and transurethral resection of prostate (TURP). During transurethral surgery, about 300mL of fluid is used to fill the bladder to secure surgical view and for irrigation. Bladder expansion causes sympathetic nerve activation and vasoconstriction, which will also increase SKNA signals. The purpose of this study is to measure skin sympathetic nerve activity according to different anesthetics during intraoperative events that stimulate sympathetic tone.
- Conditions
- SKNA According to Different Anesthetics
- Being tested
- Propofol continuous infusion, Remifentanil, Sevoflurane, Desflurane, Propofol bolus injection
- Keywords
- skin sympathetic nerve activity, anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol continuous infusionDrug
Also called Propofol Fresenius
Propofol intravenous continuous infusion for anesthetic induction and maintenance
RemifentanilDrug
Also called Ultiva
Remifentanil intravenous continuous infusion for anesthetic induction and maintenance
SevofluraneDrug
Also called Sevoflurane Inhalant Solution [Sojourn]
Study participants receive fentanyl 1mcg/kg and propofol 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane is used to maintain 1 age-related minimum alveolar concentration (MAC).
DesfluraneDrug
Also called Desflurane Inhalation Solution [Suprane]
1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance
Propofol bolus injectionDrug
Also called Anepol, Pofol
Propofol intravenous injection for anesthetic induction
FentanylDrug
Fentanyl intravenous injection for anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia (TIVA) | Experimental | Study participants are anesthetized by total intravenous anesthesia (TIVA) using propofol continuous infusion and remifentanil continuous infusion. During induction of general anesthesia, participants receive 3~5mcg/mL Propofol Fresenius and 3~5ng/mL and Remifentanil [Ultiva] as initial effect site concentrations. The effect site concentration is controlled with target-controlled infusion to maintain bispectral index (BIS) values between 40 and 60. Receives: Drug: Propofol continuous infusion; Drug: Remifentanil |
| Sevoflurane | Experimental | Study participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, sevoflurane inhalant solution [Sojourn] is used to maintain 1 age-related minimum alveolar concentration (MAC). Receives: Drug: Sevoflurane; Drug: Propofol bolus injection; Drug: Fentanyl |
| Desflurane | Experimental | Study participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane [Suprane] is used to maintain 1 age-related minimum alveolar concentration (MAC). Receives: Drug: Desflurane; Drug: Propofol bolus injection; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The skin sympathetic nerve activity (SKNA) presented as uV obtained via skin leads.
The average intraoperative SKNA divided by average SKNA before induction of general anesthesia (T0)
Measured: Intraoperative
Secondary outcomes (1)
Percent change of SKNA
Percent change of SKNA at different time points (T1-T7) compared to T0
Measured: T1: 1.5 minute after use of anesthetics, T2: 1.5 minute after use of muscle relaxant, T3: 30 seconds after intubation, T4: before bladder expansion, T5: 30 seconds after bladder expansion, T6: 30 sec after start of surgery, T7: 30sec after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Devices for measuring SKNA are need to be re-constructed, which takes considerable time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SKNA According to Different AnestheticsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763305
- Sponsor's protocol ID
- SKNA-TURB
- Status last verified
- May 2022
- First submitted
- 25 Nov 2018
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics During Transurethral Procedures
- ClinicalTrials.gov ID
- NCT03763305
- Acronym / sponsor ID
- SKNA-TURB
- Conditions
- SKNA According to Different Anesthetics
- Keywords
- skin sympathetic nerve activity, anesthetics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Devices for measuring SKNA are need to be re-constructed, which takes considerable time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Dec 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.
Skin sympathetic nerve activity (SKNA) has recently been discovered from the electrocardiogram obtained from healthy volunteers. The raw physiologic electric signal from electrodes placed on the skin was reprocessed through filtering and integration using software to produce the SKNA signal. However, no study has yet provided knowledge on the effect of anesthetics on SKNA during general anesthesia.
Detailed description
The most commonly used anesthetic techniques during general anesthesia are the total intravenous anesthesia (TIVA) and anesthesia using inhalants such as sevoflurane or desflurane. For TIVA, the combination of propofol and remifentanil has been used and remifentanil is known for increasing vagal tone and inhibiting sympathetic nervous system as other opioids do. Sevoflurane is presumed to have no effect on parasympathetic or sympathetic tone. On the other hand, desflurane induces tachycardia and is noted for activating sympathetic activity. Previous studies on sympathetic nervous activity according to different anesthetics did not directly measure sympathetic tone but have relied on indirect measures such as blood pressure, heart rate, and heart rate variability.
In order to evaluate skin sympathetic nerve activity according to different anesthetics, we will be recruiting patients undergoing transurethral procedures, where the sympathetic tone is expected to be activated during anesthesia and surgery. The transurethral procedures consist of transurethral resection of bladder (TURB) and transurethral resection of prostate (TURP). During transurethral surgery, about 300mL of fluid is used to fill the bladder to secure surgical view and for irrigation. Bladder expansion causes sympathetic nerve activation and vasoconstriction, which will also increase SKNA signals. The purpose of this study is to measure skin sympathetic nerve activity according to different anesthetics during intraoperative events that stimulate sympathetic tone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia (TIVA) | Experimental | Drug: Propofol continuous infusion, Drug: RemifentanilStudy participants are anesthetized by total intravenous anesthesia (TIVA) using propofol continuous infusion and remifentanil continuous infusion. During induction of general anesthesia, participants receive 3~5mcg/mL Propofol Fresenius and 3~5ng/mL and Remifentanil [Ultiva] as initial effect site concentrations. The effect site concentration is controlled with target-controlled infusion to maintain bispectral index (BIS) values between 40 and 60. |
| Sevoflurane | Experimental | Drug: Sevoflurane, Drug: Propofol bolus injection, Drug: FentanylStudy participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, sevoflurane inhalant solution [Sojourn] is used to maintain 1 age-related minimum alveolar concentration (MAC). |
| Desflurane | Experimental | Drug: Desflurane, Drug: Propofol bolus injection, Drug: FentanylStudy participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane [Suprane] is used to maintain 1 age-related minimum alveolar concentration (MAC). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled to undergo elective transurethral procedures under general anesthesia
Key exclusion criteria (4 listed)
- Diagnosed with autonomic dysfunction
- Current use of beta blockers
- Cardiac arrhythmia
- Absolute indication for either TIVA or inhalants, absolute contraindication for either TIVA or inhalants (adverse effects on either propofol or remifentanil, risk of malignant hyperthermia)
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 |
|---|---|---|
| Propofol continuous infusionAlso: Propofol FreseniusPropofol intravenous continuous infusion for anesthetic induction and maintenance | Drug | Total intravenous anesthesia (TIVA) |
| RemifentanilAlso: UltivaRemifentanil intravenous continuous infusion for anesthetic induction and maintenance | Drug | Total intravenous anesthesia (TIVA) |
| SevofluraneAlso: Sevoflurane Inhalant Solution [Sojourn]Study participants receive fentanyl 1mcg/kg and propofol 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane is used to maintain 1 age-related minimum alveolar concentration (MAC). | Drug | Sevoflurane |
| DesfluraneAlso: Desflurane Inhalation Solution [Suprane]1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance | Drug | Desflurane |
| Propofol bolus injectionAlso: Anepol, PofolPropofol intravenous injection for anesthetic induction | Drug | Desflurane, Sevoflurane |
| FentanylFentanyl intravenous injection for anesthetic induction | Drug | Desflurane, Sevoflurane |
Primary outcome
The skin sympathetic nerve activity (SKNA) presented as uV obtained via skin leads.
Time frame: Intraoperative
The average intraoperative SKNA divided by average SKNA before induction of general anesthesia (T0)
1 secondary outcome
Percent change of SKNA
Time frame: T1: 1.5 minute after use of anesthetics, T2: 1.5 minute after use of muscle relaxant, T3: 30 seconds after intubation, T4: before bladder expansion, T5: 30 seconds after bladder expansion, T6: 30 sec after start of surgery, T7: 30sec after end of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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, MD, PhD study director
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Propofol continuous infusion, Remifentanil and Sevoflurane in people with SKNA According to Different Anesthetics, run by Seoul National University Hospital.
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 4 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: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (SKNA) presented as uV obtained via skin leads. (time frame: Intraoperative). 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 11 May 2022.