NCT00534586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Dec 2005

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

September 26, 2007

Status Verified

December 1, 2005

First QC Date

September 24, 2007

Last Update Submit

September 24, 2007

Conditions

Healthy

Keywords

PainSSEPCHEPSPropofolSevofluraneS-KetamineRemifentanilHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • influence of different drugs on evoked responses

    2 hours

Secondary Outcomes (2)

  • 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 Arms (4)

1

ACTIVE COMPARATOR

remifentanil

Drug: Remifentanil

2

ACTIVE COMPARATOR

propofol

Drug: Propofol

3

ACTIVE COMPARATOR

sevoflurane

Drug: Sevoflurane

4

ACTIVE COMPARATOR

s-ketamine

Drug: S-Ketamine

Interventions

PropofolDRUG

TCI 0.5 mcg/ml 1.0 mcg/ml

2
RemifentanilDRUG

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

1
S-KetamineDRUG

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

4
SevofluraneDRUG

via face mask 0.40 Vol% 0.80 Vol%

3

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status 1-2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, Germany

Location

MeSH Terms

Conditions

Pain

Interventions

PropofolRemifentanilEsketamineSevoflurane

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Eberhard Kochs, MD

    Klinikum rechts der Isar der Technischen Universität München

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

December 1, 2005

Study Completion

May 1, 2007

Last Updated

September 26, 2007

Record last verified: 2005-12

Locations

DE(1)