Phase 4
N=100
Sugammadex Titration in Cardiac Surgery Patients
Coronary Artery Disease · Valvular Heart Disease · Aorta Disease · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05246397 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Total Dose of Sugammadex Required to Produce a Train-of-four Ratio of >0.9, Categorized as Greater Than or Less Than the Manufacturers Recommended Dose Based on the Train-of-four or Post Tetanic Response Prior to Administration of Sugammadex — 84; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex administration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dose of Sugammadex Required to Produce a Train-of-four Ratio of >0.9, Categorized as Greater Than or Less Than the Manufacturers Recommended Dose Based on the Train-of-four or Post Tetanic Response Prior to Administration of Sugammadex |
84; 13 | — |
| PRIMARY Duration of Action of Reversal |
2; 95 | — |
Summary
Sugammadex is frequently used to reverse the effects of neuromuscular blocking drugs. The recommended doses are 2 mg/kg or 4 mg/kg depending upon the depth of neuromuscular blockade. Clinical studies and experience have suggested that smaller doses may be effective. The purpose of this observational study is to determine the minimal effective dose of sugammadex by administering 50 mg every 5 minutes until the train-of-four ratio is 0.9 in a cohort of cardiac surgery patients, and to determine the duration of action by measuring the train-of-four every hour for up to 6 hours following reversal.
Eligibility Criteria
Inclusion Criteria
- All cardiac surgery patients
Exclusion Criteria
- Allergic or other adverse response to sugammadex
Data sourced from ClinicalTrials.gov (NCT05246397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.