Heart Rate Changes Following the Administration of Sugammadex
1 other identifier
observational
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2017
CompletedFirst Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2019
CompletedOctober 9, 2019
October 1, 2019
1.3 years
September 22, 2017
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Bradycardia during sugammadex administration
intraoperative
Study Arms (1)
Bradycardia during sugammadex administration
Recording any heart rate changes during planned administration of sugammadex.
Interventions
Recording heart rate changes during planned sugammadex administration.
Eligibility Criteria
Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.
You may qualify if:
- Patient age 0-18 years
- Anesthetic plan includes NMB reversal with sugammadex
You may not qualify if:
- Sugammadex not used during the case
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph D. Tobiaslead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman, Professor of Anesthesiology
Study Record Dates
First Submitted
September 22, 2017
First Posted
September 26, 2017
Study Start
September 6, 2017
Primary Completion
January 10, 2019
Study Completion
January 10, 2019
Last Updated
October 9, 2019
Record last verified: 2019-10