HealthyPhase 4NCT00534586
Anesthetics and Auditory, Visceral, and Heat Evoked Potentials
A Phase 4 study testing Propofol, Remifentanil and S-Ketamine in people with Healthy, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of the present study is to investigate and quantify the influence of commonly used anesthetics on auditory and pain evoked potentials. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propofol, Remifentanil and S-Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to May 2007
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-2
Who cannot join
- 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
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
Official title: Influence of Anesthetics on Sedation and Antinociception: an Analysis of Auditory Evoked, Visceral Evoked and Heat Evoked Potentials
The aim of the present study is to investigate and quantify the influence of commonly used anesthetics on auditory and pain evoked potentials.
Read the 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.
- Conditions
- Healthy
- Being tested
- Propofol, Remifentanil, S-Ketamine, Sevoflurane
- Keywords
- Pain, SSEP, CHEPS, Propofol, Sevoflurane, S-Ketamine, Remifentanil, Healthy volunteers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
TCI 0.5 mcg/ml 1.0 mcg/ml
RemifentanilDrug
continuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min
S-KetamineDrug
continuous infusion 0.25 mg/kg/h 0.50 mg/kg/h
SevofluraneDrug
via face mask 0.40 Vol% 0.80 Vol%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | remifentanil Receives: Drug: Remifentanil |
| 2 | Active comparator | propofol Receives: Drug: Propofol |
| 3 | Active comparator | sevoflurane Receives: Drug: Sevoflurane |
| 4 | Active comparator | s-ketamine Receives: Drug: S-Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
influence of different drugs on evoked responses
Measured: 2 hours
Secondary outcomes (2)
discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics
Measured: 2 hours
quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startDec 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Eberhard Kochs, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534586
- Sponsor's protocol ID
- 603/01
- Status last verified
- Dec 2005
- First submitted
- 24 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthetics on Sedation and Antinociception: an Analysis of Auditory Evoked, Visceral Evoked and Heat Evoked Potentials
- ClinicalTrials.gov ID
- NCT00534586
- Acronym / sponsor ID
- 603/01
- Conditions
- Healthy
- Keywords
- Pain, SSEP, CHEPS, Propofol, Sevoflurane, S-Ketamine, Remifentanil, Healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- May 2007 (actual)
- First posted
- 26 Sep 2007 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Remifentanilremifentanil |
| 2 | Active comparator | Drug: Propofolpropofol |
| 3 | Active comparator | Drug: Sevofluranesevoflurane |
| 4 | Active comparator | Drug: S-Ketamines-ketamine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status 1-2
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PropofolTCI 0.5 mcg/ml 1.0 mcg/ml | Drug | 2 |
| Remifentanilcontinuous infusion 0.05 mcg/kg/min 0.15 mcg/kg/min | Drug | 1 |
| S-Ketaminecontinuous infusion 0.25 mg/kg/h 0.50 mg/kg/h | Drug | 4 |
| Sevofluranevia face mask 0.40 Vol% 0.80 Vol% | Drug | 3 |
Primary outcome
influence of different drugs on evoked responses
Time frame: 2 hours
2 secondary outcomes
discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics
Time frame: 2 hours
quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil
Time frame: 2 hours
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 26 Sep 2007.
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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 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 S-Ketamine in people with Healthy, 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 1 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 26 Sep 2007. 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?
influence of different drugs on evoked responses (time frame: 2 hours). 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 26 Sep 2007.