Sedation Monitoring in ChildrenNCT01695486
Sedation Monitoring During Open Muscle Biopsy in Children
An observational study of Sedation Monitoring in Children, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Sedation Monitoring in Children
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Dec 2012
- 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 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure
Who may be able to join
- infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure
Who cannot join
- missing caregiver or patient consent
- intolerance of sedative agents in patients´medical history
- structural brain abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.
- Conditions
- Sedation Monitoring in Children
- Keywords
- BIS, Comfort, open muscle biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedation Monitoring in ChildrenStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Tschiedel, University Hospital, Essen
- Investigators
- Eva Tschiedel, MD, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695486
- Sponsor's protocol ID
- 11-4778-BO
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2012
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tschiedel E, Muller O, Schara U, Felderhoff-Muser U, Dohna-Schwake C. Sedation monitoring during open muscle biopsy in children by Comfort Score and Bispectral Index - a prospective analysis. Paediatr Anaesth. 2015 Mar;25(3):265-71. doi: 10.1111/pan.12547. Epub 2014 Oct 3.
PubMed 25279930
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Monitoring During Open Muscle Biopsy in Children
- ClinicalTrials.gov ID
- NCT01695486
- Acronym / sponsor ID
- 11-4778-BO
- Conditions
- Sedation Monitoring in Children
- Keywords
- BIS, Comfort, open muscle biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Sep 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 purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure
Key inclusion criteria (1 listed)
- infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure
Key exclusion criteria (3 listed)
- missing caregiver or patient consent
- intolerance of sedative agents in patients´medical history
- structural brain abnormalities
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
Not reported in the source record.
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 16 Sep 2014.
- Derived from this study: PubMed 25279930Tschiedel E, Muller O, Schara U, Felderhoff-Muser U, Dohna-Schwake C. Sedation monitoring during open muscle biopsy in children by Comfort Score and Bispectral Index - a prospective analysis. Paediatr Anaesth. 2015 Mar;25(3):265-71. doi: 10.1111/pan.12547. Epub 2014 Oct 3.
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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.
Eva Tschiedel, MD principal investigator
University Hospital, Essen
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 Sedation Monitoring in Children, run by University Hospital, Essen 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 3 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 16 Sep 2014. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695486, which also lists 1 linked publication.
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 16 Sep 2014.