NCT02704351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

March 4, 2016

Last Update Submit

May 3, 2023

Conditions

SuggamadexSurgery for Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Sugammadex group

sugammadex to reverse neuromuscular blockade following cardiac surgery

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Sugammadex to reverse neuromuscular blockade

Sugammadex group

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman, Professor of Anesthesiology

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 10, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

US(1)