Completed

Sedation Monitoring During Open Muscle Biopsy in Children

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 12 Months to 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: October 2011
See protocol details

Summary

Principal SponsorUniversity Hospital, Essen
Last updated: September 16, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

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

NCT01695486
Principal SponsorUniversity Hospital, Essen
Last updated: September 16, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 Months to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure
3 exclusion criteria prevent from participating
intolerance of sedative agents in patients medical history
missing caregiver or patient consent
structural brain abnormalities

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital

Essen, GermanyOpen University Hospital in Google Maps
CompletedOne Study Center
Sedation Monitoring During Open Muscle Biopsy in Children | PatLynk