Anesthetics and Auditory, Visceral, and Heat Evoked Poten... | NCT00534586

Studies
Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

NCT00534586

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Sep 26, 2007Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Healthy

Interventions

Propofol
Remifentanil
S-Ketamine
Sevoflurane

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Sep 24, 2007

First Submission Date that Met QC Criteria

Sep 24, 2007

First Posted Date

Sep 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2007

Last Update Posted Date

Sep 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	TCI 0.5 mcg/ml 1.0 mcg/ml	2
Remifentanil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
influence of different drugs on evoked responses		2 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eberhard Kochs, MD	Klinikum rechts der Isar der Technischen Universität München	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology		Munich	Bavaria		Germany

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D000077208	Remifentanil
C000629870	Esketamine
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided