Depth of AnesthesiaNCT03066024
Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth
An observational study of Depth of Anesthesia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Depth of Anesthesia
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Dec 2015
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents during anaesthesia / surgery procedure
Who may be able to join
- Children and adolescents undergoing surgery procedure
Who cannot join
- Neurosurgery
- Pre-existing neurological conditions
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Belrin
Berlin, 13353
About this study
As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.
- Conditions
- Depth of Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents | Children and adolescents for elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography monitoring changes
Measured: Up to the end of surgery
Secondary outcomes (1)
Anesthetic depth
Measured: Up to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startApr 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066024
- Sponsor's protocol ID
- Retro-Child
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2017
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth
- ClinicalTrials.gov ID
- NCT03066024
- Acronym / sponsor ID
- Retro-Child
- Conditions
- Depth of Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Feb 2017 (actual)
- 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.
As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents | – | –Children and adolescents for elective surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents during anaesthesia / surgery procedure
Key inclusion criteria (1 listed)
- Children and adolescents undergoing surgery procedure
Key exclusion criteria (2 listed)
- Neurosurgery
- Pre-existing neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electroencephalography monitoring changes
Time frame: Up to the end of surgery
1 secondary outcome
Anesthetic depth
Time frame: Up to the end of surgery
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 17 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depth of Anesthesia, run by Charite University, Berlin, Germany 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 2 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 17 Apr 2020. 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.
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?
Electroencephalography monitoring changes (time frame: Up to the end of surgery). 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 17 Apr 2020.