Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

Ketamine

Brief Summary

The aim of the present study is to investigate and quantify the influence of commonly used anesthetics on auditory and pain evoked potentials.

Intervention / Treatment

  • Propofol (DRUG)
    TCI 0.5 mcg/ml 1.0 mcg/ml
  • Remifentanil (DRUG)
    continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min
  • S-ketamine (DRUG)
    continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h
  • Sevoflurane (DRUG)
    via face mask 0.40 Vol% 0.80 Vol%

Condition or Disease

  • Healthy

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 40 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

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    Clinical Trial Dates

    Start date: Dec 01, 2005
    Primary Completion: Aug 31, 2020
    Completion Date: May 01, 2007 ACTUAL
    Study First Posted: Sep 26, 2007 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 24, 2007

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A
    No responsible party listed

    Location

    Bavaria, Germany
    Munich, Bavaria, Germany

    During surgery patients are exposed to different auditory and sensory stimuli. In this study we investigate the influence of different anesthetics to alertness and nociception. In addition to auditory stimuli (AEP as a measure of sedation), Contact Heat Evoked Potential Stimuli (CHEPS), and esophageal evoked potentials from the lower 1/3 of the esophagus are measured to quantify the effects of anesthetics. 60 Volunteers are enrolled into this study. For each drug, three different levels are measured:

    * level 1 no medication
    * level 2 low dose of medication
    * level 3 light sedation dose (volunteer responds to command)

    Four drugs are measured in the study:

    propofol, sevoflurane, S-ketamine and remifentanil.

    Participant Groups

    • remifentanil

    • propofol

    • sevoflurane

    • s-ketamine

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 40
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * American Society of Anesthesiologists (ASA) physical status 1-2

    Exclusion Criteria:

    * drugs that effect the central nervous system
    * neurological or psychiatric diseases
    * contraindications against propofol, sevoflurane, S-ketamine or remifentanil
    * any damages or loss of hearing
    * heartburn or any stomach diseases

    Primary Outcomes
    • influence of different drugs on evoked responses 2 hours
    Secondary Outcomes
    • discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics 2 hours
    • quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil 2 hours

    More Details

    NCT Number: NCT00534586
    Other IDs: 603/01
    Study URL: https://clinicaltrials.gov/study/NCT00534586
    Last updated: Sep 29, 2023