Sedation Monitoring During Open Muscle Biopsy in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eva Tschiedel, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01695486
First received: September 25, 2012
Last updated: May 26, 2014
Last verified: May 2014
  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

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)
  Eligibility

Ages Eligible for Study:   12 Months to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eva Tschiedel, MD, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01695486     History of Changes
Other Study ID Numbers: 11-4778-BO
Study First Received: September 25, 2012
Last Updated: May 26, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 26, 2014