Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics

NCT03763305 | Withdrawn

• 1 other identifier: SKNA-TURB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SKNA According to Different Anesthetics

Keywords

skin sympathetic nerve activity, anesthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Total intravenous anesthesia (TIVA)

EXPERIMENTAL

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; Drug: Remifentanil

Sevoflurane

EXPERIMENTAL

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; Drug: Propofol bolus injection; Drug: Fentanyl

Desflurane

EXPERIMENTAL

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; Drug: Propofol bolus injection; Drug: Fentanyl

Interventions

Propofol continuous infusion DRUG

Propofol intravenous continuous infusion for anesthetic induction and maintenance

Also known as: Propofol Fresenius

Total intravenous anesthesia (TIVA)

Remifentanil DRUG

Remifentanil intravenous continuous infusion for anesthetic induction and maintenance

Also known as: Ultiva

Total intravenous anesthesia (TIVA)

Sevoflurane 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).

Also known as: Sevoflurane Inhalant Solution [Sojourn]

Sevoflurane

Desflurane DRUG

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

Also known as: Desflurane Inhalation Solution [Suprane]

Desflurane

Propofol bolus injection DRUG

Propofol intravenous injection for anesthetic induction

Also known as: Anepol, Pofol

Desflurane; Sevoflurane

Fentanyl DRUG

Fentanyl intravenous injection for anesthetic induction

Desflurane; Sevoflurane

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo elective transurethral procedures under general anesthesia

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Interventions

Propofol; Remifentanil; Sevoflurane; Desflurane; Fentanyl

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Ethyl Ethers

Study Officials

• Yunseok Jeon, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: December 4, 2018
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05