AnesthesiaNCT02742012
Validation of a Multimodal Indicator of Depth of Anesthesia
An observational study of Anesthesia, run by Technical University of Munich at 3 sites in Germany.
Trial summary
The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28). The indicator previously developed shall now be tested on an independent set of data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- the study is observational
- How many people
- 257 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2015to Jun 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 250 adult patients scheduled for elective surgery under general anesthesia
Who may be able to join
- age ≥ 18 years
- elective surgery under general anesthesia
- anticipated operating time of about one hour or longer
- ASA physical status I-III
- written informed consent
Who cannot join
- chronic intake of CNS affecting drugs
- alcohol or drug abuse in the last three months
- CNS or psychiatric disease
- hardness of hearing or deafness
- abnormal gastrointestinal motility
- non-adherence to fasting guidelines, emergency surgery
Show all 11Show fewer
- anticipated difficult airway
- pregnancy
- cardiac surgery and surgery involving the head and/or neck
- postoperatively prolonged intubation
- pre- and/or postoperative intensive care treatment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinik für Anästhesiologie
Bonn, 53127
Klinikum rechts der Isar, Department of Anesthesiology
Munich, 81675
Klinik für Anästhesiologie am Helios Klinikum
Wuppertal, 42283
About this study
Official title: A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters
The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28).
The indicator previously developed shall now be tested on an independent set of data.
The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers.
The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.
- Conditions
- Anesthesia
- Being tested
- the study is observational
- Keywords
- electroencephalogram, hemodynamic monitoring, respiratory monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the study is observationalOther
the study is observational
What is being measured
The primary outcome is the main question the study is designed to answer.
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
Measured: 1 minute
Secondary outcomes (1)
the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionJun 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Ranft, Technical University of Munich
- Investigators
- Eberhard F Kochs, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742012
- Sponsor's protocol ID
- AMI-1250-KIE-0250-I
- Status last verified
- Sep 2018
- First submitted
- 25 Jun 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters
- ClinicalTrials.gov ID
- NCT02742012
- Acronym / sponsor ID
- AMI-1250-KIE-0250-I
- Conditions
- Anesthesia
- Keywords
- electroencephalogram, hemodynamic monitoring, respiratory monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Apr 2016 (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 present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28).
The indicator previously developed shall now be tested on an independent set of data.
The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers.
The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250 adult patients scheduled for elective surgery under general anesthesia
Key inclusion criteria (5 listed)
- age ≥ 18 years
- elective surgery under general anesthesia
- anticipated operating time of about one hour or longer
- ASA physical status I-III
- written informed consent
Key exclusion criteria (11 listed)
- chronic intake of CNS affecting drugs
- alcohol or drug abuse in the last three months
- CNS or psychiatric disease
- hardness of hearing or deafness
- abnormal gastrointestinal motility
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 |
|---|---|---|
| the study is observationalthe study is observational | Other | – |
Primary outcome
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
Time frame: 1 minute
1 secondary outcome
the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia
Time frame: 1 minute
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 11 Sep 2018.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Technical University of Munich at 3 sites 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 5 inclusion and 11 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness (time frame: 1 minute). 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 11 Sep 2018.