AnesthesiaPhase 4NCT01720615
Detection of Consciousness by EEG and Auditory Evoked Potentials
A Phase 4 study testing Propofol / Remifentanil and Sevoflurane / Remifentanil in people with Anesthesia and Electroencephalography/ Drug Effect, run by Technical University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Electroencephalography/ Drug Effect
- What is being tested?
- Propofol / Remifentanil and Sevoflurane / Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Apr 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-2
- Adult patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria
About this study
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.
Read the detailed description
During the past years, monitoring of anesthetic effects on the main target of anesthesia, the brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence, several processing methods have been suggested that reduce the electroencephalogram to a numerical value. In the current study, a set of EEG- and AEP parameters based on different analysis methods is tested with respect to the parameters ability in separating consciousness (reflected by responsiveness to command) from unconsciousness at the transition between these stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol is used. The study period is from induction of anesthesia until patients follow command after surgery and includes a reduction of the hypnotic agent after tracheal intubation until patients follow command. The isolated forearm technique is applied before muscle relaxants are given to maintain the ability to squeeze hand to command.
- Conditions
- Anesthesia, Electroencephalography/ Drug Effect
- Being tested
- Propofol / Remifentanil, Sevoflurane / Remifentanil
- Keywords
- EEG, AEP, Propofol, Sevoflurane, Remifentanil, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol / RemifentanilDrug
General anesthesia: Loss of consciousness and standard clinical practice
Sevoflurane / RemifentanilDrug
General anesthesia: Loss of consciousness and standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Propofol or Sevoflurane | No intervention | General anesthesia Receives: Drug: Propofol / Remifentanil; Drug: Sevoflurane / Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EEG- and AEP-parameters during loss- and return of consciousness
Measured: 1 day
Secondary outcomes (2)
Impact of muscle activity on EEG- and AEP-parameters
Measured: 1 day
Influence of anesthetics on EEG- and AEP-parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJan 2001
- Primary completionNov 2001
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Schneider, Technical University of Munich
- Investigators
- Eberhard F Kochs, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720615
- Sponsor's protocol ID
- 2001
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Consciousness by EEG and Auditory Evoked Potentials
- ClinicalTrials.gov ID
- NCT01720615
- Acronym / sponsor ID
- 2001
- Conditions
- Anesthesia, Electroencephalography/ Drug Effect
- Keywords
- EEG, AEP, Propofol, Sevoflurane, Remifentanil, General anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Nov 2001 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the past years, monitoring of anesthetic effects on the main target of anesthesia, the brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence, several processing methods have been suggested that reduce the electroencephalogram to a numerical value. In the current study, a set of EEG- and AEP parameters based on different analysis methods is tested with respect to the parameters ability in separating consciousness (reflected by responsiveness to command) from unconsciousness at the transition between these stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol is used. The study period is from induction of anesthesia until patients follow command after surgery and includes a reduction of the hypnotic agent after tracheal intubation until patients follow command. The isolated forearm technique is applied before muscle relaxants are given to maintain the ability to squeeze hand to command.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol or Sevoflurane | No intervention | Drug: Propofol / Remifentanil, Drug: Sevoflurane / RemifentanilGeneral anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1-2
- Adult patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol / RemifentanilGeneral anesthesia: Loss of consciousness and standard clinical practice | Drug | Propofol or Sevoflurane |
| Sevoflurane / RemifentanilGeneral anesthesia: Loss of consciousness and standard clinical practice | Drug | Propofol or Sevoflurane |
Primary outcome
Changes in EEG- and AEP-parameters during loss- and return of consciousness
Time frame: 1 day
2 secondary outcomes
Impact of muscle activity on EEG- and AEP-parameters
Time frame: 1 day
Influence of anesthetics on EEG- and AEP-parameters
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eberhard F Kochs, MD study chair
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol / Remifentanil and Sevoflurane / Remifentanil in people with Anesthesia and Electroencephalography/ Drug Effect, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EEG- and AEP-parameters during loss- and return of consciousness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.