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Sedation Monitoring During Open Muscle Biopsy in Children

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ClinicalTrials.gov Identifier: NCT01695486
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
Eva Tschiedel, University Hospital, Essen

Brief Summary:
The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.

Condition or disease
Sedation Monitoring in Children

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure
Criteria

Inclusion Criteria:

  • infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure

Exclusion Criteria:

  • missing caregiver or patient consent
  • intolerance of sedative agents in patients´medical history
  • structural brain abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695486


Locations
Germany
University Hospital
Essen, NRW, Germany, 45122
Sponsors and Collaborators
University Hospital, Essen
Investigators
Principal Investigator: Eva Tschiedel, MD University Hospital, Essen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Tschiedel, MD, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01695486     History of Changes
Other Study ID Numbers: 11-4778-BO
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by Eva Tschiedel, University Hospital, Essen:
BIS
Comfort
open muscle biopsy