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Completed

NCT Number: NCT00534586

Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

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

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology

Munich, Bavaria, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%

Primary outcomes

  1. influence of different drugs on evoked responses

    Time frame: 2 hours

Secondary outcomes

  1. discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics

    Time frame: 2 hours

  2. quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Influence of Anesthetics on Sedation and Antinociception: an Analysis of Auditory Evoked, Visceral Evoked and Heat Evoked Potentials

Important dates

Study start
2005
Study completion
2007
First posted
Sep 26, 2007
Registry last updated
Sep 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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