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Sedation Monitoring During Open Muscle Biopsy in Children

This study has been completed.
Information provided by (Responsible Party):
Eva Tschiedel, University Hospital, Essen Identifier:
First received: September 25, 2012
Last updated: September 15, 2014
Last verified: September 2014
The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.

Sedation Monitoring in Children

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by University Hospital, Essen:

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01695486

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eva Tschiedel, MD, University Hospital, Essen Identifier: NCT01695486     History of Changes
Other Study ID Numbers: 11-4778-BO
Study First Received: September 25, 2012
Last Updated: September 15, 2014

Keywords provided by University Hospital, Essen:
open muscle biopsy processed this record on April 28, 2017