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Heart Rate Changes Following the Administration of Sugammadex

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: NCT03294018
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Bradycardia Other: Recording heart rate changes

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Study Type : Observational
Actual Enrollment : 276 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heart Rate Changes Following the Administration of Sugammadex
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bradycardia during sugammadex administration
Recording any heart rate changes during planned administration of sugammadex.
Other: Recording heart rate changes
Recording heart rate changes during planned sugammadex administration.




Primary Outcome Measures :
  1. Bradycardia during sugammadex administration [ Time Frame: intraoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Sugammadex not used during the case

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): NCT03294018


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

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Responsible Party: Joseph D. Tobias, Chairman, Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03294018     History of Changes
Other Study ID Numbers: IRB17-00540
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes