Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03763305
Other study ID # SKNA-TURB
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2023

Study information

Verified date May 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. However, no study has yet provided knowledge on the effect of anesthetics on SKNA during general anesthesia.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Scheduled to undergo elective transurethral procedures under general anesthesia Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms

  • SKNA According to Different Anesthetics

Intervention

Drug:
Propofol continuous infusion
Propofol intravenous continuous infusion for anesthetic induction and maintenance
Remifentanil
Remifentanil intravenous continuous infusion for anesthetic induction and maintenance
Sevoflurane
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).
Desflurane
1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance
Propofol bolus injection
Propofol intravenous injection for anesthetic induction
Fentanyl
Fentanyl intravenous injection for anesthetic induction

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Intraoperative
Secondary Percent change of SKNA Percent change of SKNA at different time points (T1-T7) compared to T0 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