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CompletedNCT02704351Updated May 6, 2023

Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country

An observational study in Suggamadex and Surgery for Congenital Heart Disease, sponsored by Joseph D. Tobias. Completed at 1 site in United States. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Joseph D. Tobias · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
14
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Suggamadex
  • Surgery for Congenital Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 14 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Joseph D. Tobias is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • Sugammadex group

    sugammadex to reverse neuromuscular blockade following cardiac surgery

    Procedure: Surgery

Interventions

  • ProcedureSurgery

    Sugammadex to reverse neuromuscular blockade

06

What researchers measure

Primary outcomes

  1. Clinical effects of the reversal of neuromuscular blockade with suggamadex following surgery for congenital heart disease in infants and children

    Time frame: After cardiac surgery, on average within 5 minutes

07

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02704351
Lead sponsor
Joseph D. Tobias
Responsible party
Joseph D. Tobias (Chairman, Professor of Anesthesiology, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Mar 10, 2016
Start date
Feb 2016
Primary completion
Aug 2016
Completion
Aug 2016
Last update
May 6, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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