Heart Rate Changes Following the Administration of Sugamm... | NCT03294018

Studies
Heart Rate Changes Following the Administration of Sugammadex

NCT03294018

Sponsor

Joseph D. Tobias

Status

Completed

Last Update Posted

Oct 9, 2019Actual

Enrollment

276Actual

Phase

Not provided

Conditions

Bradycardia

Interventions

Recording heart rate changes

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

Oct 2019

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

Sep 6, 2017Actual

Primary Completion Date

Jan 10, 2019Actual

Completion Date

Jan 10, 2019Actual

First Submitted Date

Sep 22, 2017

First Submission Date that Met QC Criteria

Sep 22, 2017

First Posted Date

Sep 26, 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

Oct 8, 2019

Last Update Posted Date

Oct 9, 2019Actual

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)

Not provided

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

This a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. If bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded.

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

276Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bradycardia during sugammadex administration		Recording any heart rate changes during planned administration of sugammadex.	Other: Recording heart rate changes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recording heart rate changes	Other	Recording heart rate changes during planned sugammadex administration.	Bradycardia during sugammadex administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bradycardia during sugammadex administration		intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age 0-18 years
Anesthetic plan includes NMB reversal with sugammadex

Exclusion Criteria:

Sugammadex not used during the case

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.

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

Condition Browse Module

MeSH Terms

ID	Term
D001919	Bradycardia

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided