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Sedation Monitoring During Open Muscle Biopsy in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695486
First Posted: September 28, 2012
Last Update Posted: September 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva Tschiedel, University Hospital, Essen
  Purpose
The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.

Condition
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 Eva Tschiedel, 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)
  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: September 25, 2012
First Posted: September 28, 2012
Last Update Posted: September 16, 2014
Last Verified: September 2014

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