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Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534586
First Posted: September 26, 2007
Last Update Posted: September 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00534586     History of Changes
Other Study ID Numbers: 603/01
First Submitted: September 24, 2007
First Posted: September 26, 2007
Last Update Posted: September 26, 2007
Last Verified: December 2005

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

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