Suggamadex and Fast-track Cardiac Anesthesia in a Develop... | NCT02704351

Studies
Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country

NCT02704351

Sponsor

Joseph D. Tobias

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Suggamadex
Surgery for Congenital Heart Disease

Interventions

Surgery

Countries

United States

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

May 2023

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

Feb 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 4, 2016

First Submission Date that Met QC Criteria

Mar 4, 2016

First Posted Date

Mar 10, 2016Estimated

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

May 3, 2023

Last Update Posted Date

May 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph D. Tobias, Chairman, Professor of Anesthesiology, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Joseph D. TobiasOTHER

Collaborators

Not provided

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 retrospectively review our preliminary experience during a surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following CPB and cardiac surgery for repair of CHD in infants and 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

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sugammadex group		sugammadex to reverse neuromuscular blockade following cardiac surgery	Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Sugammadex to reverse neuromuscular blockade	Sugammadex group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical effects of the reversal of neuromuscular blockade with suggamadex following surgery for congenital heart disease in infants and children		After cardiac surgery, on average within 5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent cardiac surgery and cardiopulmonary bypass in Tuxtla, Mexico in September 2015.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Last September 2015, patients in Tuxtla, Mexico who underwent cardiac surgery and cardiopulmonary bypass surgery for congenital heart defect where suggamadex was used for reversal of neuromuscular blockade.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided