Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

• ClinicalTrials.gov Identifier: NCT03763305
• Recruitment Status: Unknown
• First Posted: December 4, 2018
• Last Update Posted: December 4, 2018
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Yunseok Jeon, Seoul National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
SKNA According to Different Anesthetics	Drug: Propofol continuous infusion; Drug: Remifentanil; Drug: Sevoflurane; Drug: Desflurane; Drug: Propofol bolus injection; Drug: Fentanyl	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 177 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics During Transurethral Procedures
• Estimated Study Start Date: December 1, 2018
• Estimated Primary Completion Date: June 1, 2020
• Estimated Study Completion Date: December 1, 2020

Arms and Interventions

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 Name: Propofol Fresenius; Drug: Remifentanil; Remifentanil intravenous continuous infusion for anesthetic induction and maintenance; Other Name: 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 Name: 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: Desflurane; 1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance; Other Name: Desflurane Inhalation Solution [Suprane]; Drug: Propofol bolus injection; Propofol intravenous injection for anesthetic induction; Other Names: Anepol; Pofol; Drug: Fentanyl; Fentanyl intravenous injection for anesthetic induction

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]
   Percent change of SKNA at different time points (T1-T7) compared to T0

Eligibility Criteria

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

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)

Contacts and Locations

Contacts

Contact: Yunseok Jeon, MD, PhD; +82 2 2072 3108; jeonyunseok@gmail.com

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

More Information

• Responsible Party: Yunseok Jeon, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03763305
• Other Study ID Numbers: SKNA-TURB
• First Posted: December 4, 2018
• Last Update Posted: December 4, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yunseok Jeon, Seoul National University Hospital:

skin sympathetic nerve activity, anesthetics

Additional relevant MeSH terms:

Fentanyl; Remifentanil; Propofol; Sevoflurane; Desflurane; Pharmaceutical Solutions; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Platelet Aggregation Inhibitors; Anesthetics, Inhalation