Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

NCT ID: NCT03763305

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

SKNA According to Different Anesthetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Propofol continuous infusion

Intervention Type: DRUG

Propofol intravenous continuous infusion for anesthetic induction and maintenance

Remifentanil

Intervention Type: DRUG

Remifentanil intravenous continuous infusion for anesthetic induction and maintenance

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).

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

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).

Propofol bolus injection

Intervention Type: DRUG

Propofol intravenous injection for anesthetic induction

Fentanyl

Intervention Type: DRUG

Fentanyl intravenous injection for anesthetic induction

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).

Group Type: EXPERIMENTAL

Desflurane

Intervention Type: DRUG

1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance

Propofol bolus injection

Intervention Type: DRUG

Propofol intravenous injection for anesthetic induction

Fentanyl

Intervention Type: DRUG

Fentanyl intravenous injection for anesthetic induction

Interventions

Propofol continuous infusion

Propofol intravenous continuous infusion for anesthetic induction and maintenance

Intervention Type: DRUG

Remifentanil

Remifentanil intravenous continuous infusion for anesthetic induction and maintenance

Intervention Type: 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).

Intervention Type: DRUG

Desflurane

1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance

Intervention Type: DRUG

Propofol bolus injection

Propofol intravenous injection for anesthetic induction

Intervention Type: DRUG

Fentanyl

Fentanyl intravenous injection for anesthetic induction

Intervention Type: DRUG

Other Intervention Names

Propofol Fresenius; Ultiva; Sevoflurane Inhalant Solution [Sojourn]; Desflurane Inhalation Solution [Suprane]; Anepol; Pofol

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yunseok Jeon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunseok Jeon, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Other Identifiers

SKNA-TURB

Identifier Type: -

Identifier Source: org_study_id