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Clinical Trials/NCT00534586
NCT00534586
Completed
Phase 4

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

Technical University of Munich1 site in 1 country60 target enrollmentDecember 2005

Overview

Phase
Phase 4
Intervention
Remifentanil
Conditions
Healthy
Sponsor
Technical University of Munich
Enrollment
60
Locations
1
Primary Endpoint
influence of different drugs on evoked responses
Status
Completed
Last Updated
18 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
May 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Technical University of Munich

Eligibility 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

Arms & Interventions

1

remifentanil

Intervention: Remifentanil

2

propofol

Intervention: Propofol

3

sevoflurane

Intervention: Sevoflurane

4

s-ketamine

Intervention: S-Ketamine

Outcomes

Primary Outcomes

influence of different drugs on evoked responses

Time Frame: 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)

Study Sites (1)

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