NCT01720615

Brief Summary

The objective of the present investigation is to analyze EEG and auditory evoked potentials at the transition from consciousness to unconsciousness and vice versa. A set of electroencephalographic and auditory evoked potential parameters should be identified that allows separation of consciousness from unconsciousness (reflected by responsiveness/unresponsiveness to command). The study is based on data of 80 patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2001

Typical duration for phase_4

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

January 1, 2001

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

October 29, 2012

Last Update Submit

October 31, 2012

Conditions

AnesthesiaElectroencephalography/ Drug Effect

Keywords

EEGAEPPropofolSevofluraneRemifentanilGeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Changes in EEG- and AEP-parameters during loss- and return of consciousness

    1 day

Secondary Outcomes (2)

  • Impact of muscle activity on EEG- and AEP-parameters

    1 day

  • Influence of anesthetics on EEG- and AEP-parameters

    1 day

Study Arms (1)

Propofol or Sevoflurane

NO INTERVENTION

General anesthesia

Drug: Propofol / RemifentanilDrug: Sevoflurane / Remifentanil

Interventions

Propofol / RemifentanilDRUG

General anesthesia: Loss of consciousness and standard clinical practice

Propofol or Sevoflurane
Sevoflurane / RemifentanilDRUG

General anesthesia: Loss of consciousness and standard clinical practice

Propofol or Sevoflurane

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with contraindications to the study drugs
  • psychiatric or neurologic disease
  • drug abuse or medication known to affect the central nervous system
  • pregnancy
  • indication for rapid sequence induction

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

Interventions

PropofolRemifentanilSevoflurane

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eberhard F Kochs, MD

    Klinikum rechts der Isar Technische Universität München

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 2, 2012

Study Start

January 1, 2001

Primary Completion

November 1, 2001

Study Completion

April 1, 2003

Last Updated

November 2, 2012

Record last verified: 2012-10

Locations

DE(1)