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Clinical trial

Sugammadex Titration for Reversal of Rocuronium or Vecuronium in Cardiac Surgery Patients

ID
Name
STUDY00013925
Description
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.
Trial arms
Trial start
2022-02-01
Estimated PCD
2022-11-10
Trial end
2022-11-10
Status
Completed
Phase
Early phase I
Treatment
Sugammadex administration
Sugammadex will be given in 50 mg increments every five minutes for reversal of neuromuscular blockade until reaching a train-of-four ratio of 0.9
Arms:
Cardiac surgery patients
Size
100
Primary endpoint
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
At the completion of surgery and prior to transport to the intensive care unit. The elapsed time from completion of surgery to arrival in the intensive care unit is 30 min to 1 hour
Duration of Action of Reversal
On arrival to the intensive care unit and hourly thereafter for 6 hours or until extubation, whichever occurs first
Eligibility criteria
Inclusion Criteria * All cardiac surgery patients Exclusion Criteria: * Allergic or other adverse response to sugammadex
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2024-03-21

1 organization

1 product

4 indications

Organization
University of Washington
Product
Sugammadex
Indication
Coronary Artery Disease
Indication
Valvular Heart Disease
Indication
Aortic Disease
Indication
Congestive Heart Failure