Sedation Monitoring During Open Muscle Biopsy in Children | NCT01695486

Studies
Sedation Monitoring During Open Muscle Biopsy in Children

NCT01695486

Sponsor

University Hospital, Essen

Status

Completed

Last Update Posted

Sep 16, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Sedation Monitoring in Children

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 25, 2012

First Submission Date that Met QC Criteria

Sep 27, 2012

First Posted Date

Sep 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2014

Last Update Posted Date

Sep 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Tschiedel, MD	University Hospital, Essen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Essen	North Rhine-Westphalia	45122	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25279930	Derived	Tschiedel E, Muller O, Schara U, Felderhoff-Muser U, Dohna-Schwake C. Sedation monitoring during open muscle biopsy in children by Comfort Score and Bispectral Index - a prospective analysis. Paediatr Anaesth. 2015 Mar;25(3):265-71. doi: 10.1111/pan.12547. Epub 2014 Oct 3.