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Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00534586
First received: September 24, 2007
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Propofol
Drug: Remifentanil
Drug: S-Ketamine
Drug: Sevoflurane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Influence of Anesthetics on Sedation and Antinociception: an Analysis of Auditory Evoked, Visceral Evoked and Heat Evoked Potentials

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • influence of different drugs on evoked responses [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics [ Time Frame: 2 hours ]
  • quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil [ Time Frame: 2 hours ]

Enrollment: 60
Study Start Date: December 2005
Study Completion Date: May 2007
Arms Assigned Interventions
Active Comparator: 1
remifentanil
 Drug: Remifentanil
continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min
Active Comparator: 2
propofol
 Drug: Propofol
TCI 0.5 mcg/ml 1.0 mcg/ml
Active Comparator: 3
sevoflurane
 Drug: Sevoflurane
via face mask 0.40 Vol% 0.80 Vol%
Active Comparator: 4
s-ketamine
 Drug: S-Ketamine
continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534586

Locations
Germany
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria, Germany
Sponsors and Collaborators
Technische Universität München
Investigators
Study Chair: Eberhard Kochs, MD Klinikum rechts der Isar der Technischen Universität München
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534586     History of Changes
Other Study ID Numbers: 603/01
Study First Received: September 24, 2007
Last Updated: September 24, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Pain
SSEP
CHEPS
Propofol
 Sevoflurane
S-Ketamine
Remifentanil
Healthy volunteers

Additional relevant MeSH terms:
Anesthetics
Ketamine
Propofol
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013