Myorelaxation Practice in Paediatric Anesthesia | NCT03086915

Studies
Myorelaxation Practice in Paediatric Anesthesia

NCT03086915

Sponsor

Brno University Hospital

Status

Completed

Last Update Posted

Nov 19, 2018Actual

Enrollment

1,650Actual

Phase

Not provided

Conditions

Neuromuscular Blockade

Interventions

Neuromuscular Blocking Agent

Countries

Czechia

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

Nov 2018

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

Mar 5, 2017Actual

Primary Completion Date

Jul 30, 2017Actual

Completion Date

Aug 1, 2017Actual

First Submitted Date

Mar 5, 2017

First Submission Date that Met QC Criteria

Mar 16, 2017

First Posted Date

Mar 22, 2017Actual

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

Nov 16, 2018

Last Update Posted Date

Nov 19, 2018Actual

Name	Class
Masaryk University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified.

Detailed Description

The actual percentage of surgeries with the muscle relaxants administered during perioperative period in paediatric patients remain unclear because many surgeries are being performed without muscle relaxation. In this retrospective study, the anesthesiology perioperative data from January 2016 till December 2016 in the tertiary center od Pediatric anesthesia will be searched for the percentage of surgeries with muscle relaxants administered. Type of surgery, age, weight, duration u surgery, muscle relaxants drug and percentage of block reversal will be identified.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

1,650Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with neuromuscular block		Neuromuscular blocking agent administrated during surgery to the paediatric patient	Drug: Neuromuscular Blocking Agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuromuscular Blocking Agent	Drug	Administration of neuromuscular blockers during anesthesia	Patients with neuromuscular block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of neuromuscular block reversal	The actual percentage of paediatric patients with perioperative neuromuscular blockade with active pharmacology block reversal at the end of surgery	1 year

Secondary Outcomes

Measure	Description	Time Frame
Percentage of surgeries without muscle relaxant administration	Paediatric surgeries without neuromuscular blocking agent administration	1 year
Type of neuromuscular blocking agent in paediatric anesthesiology practice

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

paediatric patients
the study period (1/2016-12/2016)
neuromuscular blocking agent administration during surgery

Exclusion Criteria:

surgery without neuromuscular blockade

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Paediatric anesthesiology patients who underwent surgery with neuromuscular blocking agent administered during surgery in tertiary center paediatric anesthesiology department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brno University Hospital		Brno		62500	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009123	Muscle Hypotonia

Ancestor Terms

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009466	Neuromuscular Blocking Agents

Ancestor Terms

ID	Term
D009465	Neuromuscular Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided