ClinicalTrials.gov
ClinicalTrials.gov Menu

Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02704351
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Suggamadex Surgery for Congenital Heart Disease Procedure: Surgery

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Chart Review of Fast-track Cardiac Anesthesia Using Suggamadex for Rapid Reversal of Neuromuscular Blockade Following Cardiac Surgery in a Developing Country
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
Drug Information available for: Sugammadex

Group/Cohort Intervention/treatment
Sugammadex group
sugammadex to reverse neuromuscular blockade following cardiac surgery
Procedure: Surgery
Sugammadex to reverse neuromuscular blockade




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704351


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias

Responsible Party: Joseph D. Tobias, Chairman, Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02704351     History of Changes
Other Study ID Numbers: IRB15-01162
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases