Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Remifentanil; Drug: Propofol; Drug: Sevoflurane; Drug: S-Ketamine

• Registration Number: NCT00534586
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Status Verified: 2005-12
• Study Start: 2005-12
• Study Completion: 2007-05
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Last Update Submitted: 2007-09-24
• Study First Posted: 2007-09-26
• Last Update Posted: 2007-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Remifentanil	remifentanil
2	Propofol	propofol
3	Sevoflurane	sevoflurane
4	S-Ketamine	s-ketamine

Primary Outcome Measures

Name	Time	Method
influence of different drugs on evoked responses	2 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology; 🇩🇪 Munich, Bavaria, Germany