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Clinical Trials/NCT03763305
NCT03763305
Withdrawn
N/A

Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics During Transurethral Procedures

Overview

Phase
N/A
Intervention
Propofol continuous infusion
Conditions
SKNA According to Different Anesthetics
Sponsor
Seoul National University Hospital
Primary Endpoint
The skin sympathetic nerve activity (SKNA) presented as uV obtained via skin leads.
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yunseok Jeon

Professor

Seoul National University Hospital

Eligibility Criteria

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)

Arms & Interventions

Total intravenous anesthesia (TIVA)

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.

Intervention: Propofol continuous infusion

Total intravenous anesthesia (TIVA)

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.

Intervention: Remifentanil

Sevoflurane

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).

Intervention: Sevoflurane

Sevoflurane

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).

Intervention: Propofol bolus injection

Sevoflurane

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).

Intervention: Fentanyl

Desflurane

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).

Intervention: Desflurane

Desflurane

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).

Intervention: Propofol bolus injection

Desflurane

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).

Intervention: Fentanyl

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Percent change of SKNA(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)

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