Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

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.

Study Overview

• Status: Withdrawn
• Conditions: SKNA According to Different Anesthetics
• Intervention / Treatment: Drug: Propofol continuous infusion; Drug: Remifentanil; Drug: Sevoflurane; Drug: Propofol bolus injection; Drug: Fentanyl; Drug: Desflurane

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Propofol continuous infusion; Propofol intravenous continuous infusion for anesthetic induction and maintenance; Other Names: Propofol Fresenius; Drug: Remifentanil; Remifentanil intravenous continuous infusion for anesthetic induction and maintenance; Other Names: Ultiva
Experimental: 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).	Drug: 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).; Other Names: Sevoflurane Inhalant Solution [Sojourn]; Drug: Propofol bolus injection; Propofol intravenous injection for anesthetic induction; Other Names: Anepol; Pofol; Drug: Fentanyl; Fentanyl intravenous injection for anesthetic induction
Experimental: 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).	Drug: Propofol bolus injection; Propofol intravenous injection for anesthetic induction; Other Names: Anepol; Pofol; Drug: Fentanyl; Fentanyl intravenous injection for anesthetic induction; Drug: Desflurane; 1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance; Other Names: Desflurane Inhalation Solution [Suprane]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Yunseok Jeon, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: skin sympathetic nerve activity, anesthetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Remifentanil; Fentanyl; Propofol; Desflurane; Pharmaceutical Solutions; Sevoflurane
• Other Study ID Numbers: SKNA-TURB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No