AnesthesiaNCT02766894
Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
An observational study of Anesthesia, run by Kepler University Hospital.
Trial summary
Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate, deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch statistical analysis for underlying factors are done. Read more about this study
- Who is it for?
- Ages 1 year to 110 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- EEG monitoring
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Mar 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 1 year to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients: Randomization of patients (m/w) after informed consent. For detailed inclusion criteria see corresponding section. Patients are randomly assigned to anesthesiologist. Anesthesiologists are blinded and must assume anesthesia level. Evaluation will be performed by study leader.
Who may be able to join
- operation under general anesthesia
- duration of surgery ≥ 10 minutes
- informed consent
- ASA physical status 1-4
- age 1-110y
- performance check of Narcotrend
Who cannot join
- proximity of EEG electrodes to the operating field
- frontal skin lesion
- frontal cerebral pathology
- hypoxic brain damage
- hypothermia (≤33°C)
- language barrier
About this study
Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate, deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch statistical analysis for underlying factors are done.
Read the detailed description
In this observational study estimation of anesthetic depth by anesthesiologists is compared with the EEG based monitoring Narcotrend®. 10-20 voluntary anesthesiologists of the Kepler University Hospital, unfamiliar with EEG-monitoring during anesthesia, assess depth of anesthesia (moderate, deep or light level) during a steady-state period by clinical signs and measured or calculated concentrations of anesthetics. Concurrently Narcotrend® provides data of anesthetic depth (index, stadium) blinded for the anesthesiologist. Each anesthesiologist is included 30 times during study period. The aim of this study is to define conformity between subjective and objective assessment of narcotic depth. In the cases of divergence data of the patient (age, body mass index, comorbidity…), data of the anesthesiologist (age, years of practice…), data of anesthesia (balanced anesthesia, target controlled infusion, endtidal concentration of volatile anesthetic…) and data of the operation (eye surgery, cardiac surgery…) will be analyzed by statistics with regard to underlying or concomitant factors. These findings could help to develop recommendations in the use of EEG-processed monitoring to improve subjective assessment and facilitate an adequate depth of anesthesia to be provided for every patient.
- Conditions
- Anesthesia
- Being tested
- EEG monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDevice
EEG will be performed. Data obtained will be analyzed using software. Anesthesiologists will enter their assumption in a blinded fashion and data obtained will be compared with EEG data
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth.
Depth of anesthesia will be assessed by the anesthesiologist in an subjective way. During a defined period of stable anesthesia state, the indicated subjective depth levels will be assessed by the anesthesiologist and will be compared to those obtained by narcotrend (Narcotrend-Index). Anesthesiologists will assess by deep, moderate and superficial depth of anesthesia. Narcotrend indices will also be assigned to three groups (superficial, moderate, deep levels). After the procedure, both systems will be compared. In the case of non-correlation, other factors like i.e. patient's age, comorbidities, years of practice of the anesthesiologist etc. will be analysed for any other type of correlation.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Puchner MD, Kepler University Hospital
- Investigators
- Jens Meier, MD, PhD, Study chair, Kepler UH, Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766894
- Sponsor's protocol ID
- C-109-16
- Status last verified
- Aug 2017
- First submitted
- 1 May 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be accessible on central server to observers after completion of the study
Publications
Kreuer S, Bruhn J, Stracke C, Aniset L, Silomon M, Larsen R, Wilhelm W. Narcotrend or bispectral index monitoring during desflurane-remifentanil anesthesia: a comparison with a standard practice protocol. Anesth Analg. 2005 Aug;101(2):427-434. doi: 10.1213/01.ANE.0000157565.00359.E2.
PubMed 16037157Bauerle K, Greim CA, Schroth M, Geisselbrecht M, Kobler A, Roewer N. Prediction of depth of sedation and anaesthesia by the Narcotrend EEG monitor. Br J Anaesth. 2004 Jun;92(6):841-5. doi: 10.1093/bja/aeh142. Epub 2004 Apr 2.
PubMed 15064250Puchner WF, Dunser MW, Paulus P, Neuner MP, Mayer CL, Pomberger IM, Hackl R, Meier JM. A comparative study on adequate anesthesia depth: clinical judgement and the Narcotrend(R) measurement. Can J Anaesth. 2020 Jun;67(6):664-673. doi: 10.1007/s12630-020-01602-x. Epub 2020 Mar 3.
PubMed 32128723
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
- ClinicalTrials.gov ID
- NCT02766894
- Acronym / sponsor ID
- C-109-16
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 May 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.
Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate, deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch statistical analysis for underlying factors are done.
Detailed description
In this observational study estimation of anesthetic depth by anesthesiologists is compared with the EEG based monitoring Narcotrend®. 10-20 voluntary anesthesiologists of the Kepler University Hospital, unfamiliar with EEG-monitoring during anesthesia, assess depth of anesthesia (moderate, deep or light level) during a steady-state period by clinical signs and measured or calculated concentrations of anesthetics. Concurrently Narcotrend® provides data of anesthetic depth (index, stadium) blinded for the anesthesiologist. Each anesthesiologist is included 30 times during study period. The aim of this study is to define conformity between subjective and objective assessment of narcotic depth. In the cases of divergence data of the patient (age, body mass index, comorbidity…), data of the anesthesiologist (age, years of practice…), data of anesthesia (balanced anesthesia, target controlled infusion, endtidal concentration of volatile anesthetic…) and data of the operation (eye surgery, cardiac surgery…) will be analyzed by statistics with regard to underlying or concomitant factors. These findings could help to develop recommendations in the use of EEG-processed monitoring to improve subjective assessment and facilitate an adequate depth of anesthesia to be provided for every patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients: Randomization of patients (m/w) after informed consent. For detailed inclusion criteria see corresponding section. Patients are randomly assigned to anesthesiologist. Anesthesiologists are blinded and must assume anesthesia level. Evaluation will be performed by study leader.
Key inclusion criteria (6 listed)
- operation under general anesthesia
- duration of surgery ≥ 10 minutes
- informed consent
- ASA physical status 1-4
- age 1-110y
Key exclusion criteria (6 listed)
- proximity of EEG electrodes to the operating field
- frontal skin lesion
- frontal cerebral pathology
- hypoxic brain damage
- hypothermia (≤33°C)
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 |
|---|---|---|
| EEG monitoringEEG will be performed. Data obtained will be analyzed using software. Anesthesiologists will enter their assumption in a blinded fashion and data obtained will be compared with EEG data | Device | – |
Primary outcome
Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth.
Time frame: up to 1 year
Depth of anesthesia will be assessed by the anesthesiologist in an subjective way. During a defined period of stable anesthesia state, the indicated subjective depth levels will be assessed by the anesthesiologist and will be compared to those obtained by narcotrend (Narcotrend-Index). Anesthesiologists will assess by deep, moderate and superficial depth of anesthesia. Narcotrend indices will also be assigned to three groups (superficial, moderate, deep levels). After the procedure, both systems will be compared. In the case of non-correlation, other factors like i.e. patient's age, comorbidities, years of practice of the anesthesiologist etc. will be analysed for any other type of correlation.
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 22 Aug 2017.
- Background: PubMed 16037157Kreuer S, Bruhn J, Stracke C, Aniset L, Silomon M, Larsen R, Wilhelm W. Narcotrend or bispectral index monitoring during desflurane-remifentanil anesthesia: a comparison with a standard practice protocol. Anesth Analg. 2005 Aug;101(2):427-434. doi: 10.1213/01.ANE.0000157565.00359.E2.
- Background: PubMed 15064250Bauerle K, Greim CA, Schroth M, Geisselbrecht M, Kobler A, Roewer N. Prediction of depth of sedation and anaesthesia by the Narcotrend EEG monitor. Br J Anaesth. 2004 Jun;92(6):841-5. doi: 10.1093/bja/aeh142. Epub 2004 Apr 2.
- Derived from this study: PubMed 32128723Puchner WF, Dunser MW, Paulus P, Neuner MP, Mayer CL, Pomberger IM, Hackl R, Meier JM. A comparative study on adequate anesthesia depth: clinical judgement and the Narcotrend(R) measurement. Can J Anaesth. 2020 Jun;67(6):664-673. doi: 10.1007/s12630-020-01602-x. Epub 2020 Mar 3.
- Individual participant dataSharing planned: Yes. Data will be accessible on central server to observers after completion of the study
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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.
Jens Meier, MD, PhD study chair
Kepler UH, Dept. of Anesthesiology
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Kepler University Hospital.
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 6 inclusion and 6 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766894, which also lists 3 linked publications.
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 22 Aug 2017.