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Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

NCT ID: NCT00534586

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Pain SSEP CHEPS Propofol Sevoflurane S-Ketamine Remifentanil Healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

remifentanil

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min

2

propofol

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

TCI 0.5 mcg/ml 1.0 mcg/ml

3

sevoflurane

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

via face mask 0.40 Vol% 0.80 Vol%

4

s-ketamine

Group Type ACTIVE_COMPARATOR

S-Ketamine

Intervention Type DRUG

continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h

Interventions

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Propofol

TCI 0.5 mcg/ml 1.0 mcg/ml

Intervention Type DRUG

Remifentanil

continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min

Intervention Type DRUG

S-Ketamine

continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h

Intervention Type DRUG

Sevoflurane

via face mask 0.40 Vol% 0.80 Vol%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Principal Investigators

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Eberhard Kochs, MD

Role: STUDY_CHAIR

Klinikum rechts der Isar der Technischen Universität München

Locations

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

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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603/01

Identifier Type: -

Identifier Source: org_study_id