Heart Rate Changes Following the Administration of Sugammadex

Bradycardia Clinical Trial

Official title:

Heart Rate Changes Following the Administration of Sugammadex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294018
• Other study ID #: IRB17-00540
• Status: Completed
• Start date: September 6, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: October 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patient age 0-18 years

• Anesthetic plan includes NMB reversal with sugammadex

Exclusion Criteria:

• Sugammadex not used during the case

Related Conditions & MeSH terms

• Bradycardia

Intervention

Other:
• Recording heart rate changes
Recording heart rate changes during planned sugammadex administration.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bradycardia during sugammadex administration		intraoperative