Trial Outcomes & Findings for Sugammadex Titration in Cardiac Surgery Patients (NCT NCT05246397)

Last Updated: 2024-03-21

Results Overview

Sugammadex will be administered in 50 mg increments every 5 minutes until a train-of-four ratio of at least 0.9 is reached. The total dose of sugammadex for each patient will be categorized as greater than or less than the manufacturers recommended dose

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2024-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiac Surgery Patients Patients undergoing cardiac surgery 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
Overall Study STARTED	100
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cardiac Surgery Patients Patients undergoing cardiac surgery 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
Overall Study 3 were excluded due to protocol deviation	3

Baseline Characteristics

Sugammadex Titration in Cardiac Surgery Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Surgery Patients n=97 Participants Patients undergoing cardiac surgery 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
Age, Continuous	58 years STANDARD_DEVIATION 15 • n=99 Participants
Sex/Gender, Customized Female	23 Participants n=99 Participants
Sex/Gender, Customized Male	73 Participants n=99 Participants
Sex/Gender, Customized Other	1 Participants n=99 Participants
Race/Ethnicity, Customized Asian	8 Participants n=99 Participants
Race/Ethnicity, Customized White	77 Participants n=99 Participants
Race/Ethnicity, Customized Other	12 Participants n=99 Participants
Region of Enrollment United States	97 Participants n=99 Participants
Weight	80 kilograms n=99 Participants
Creatinine	0.9 mg/dL n=99 Participants
Hemoglobin	9.2 g/dL STANDARD_DEVIATION 1.6 • n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Cardiac Surgery Patients n=97 Participants Patients undergoing cardiac surgery 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
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 Less than manufacturer's dose	84 Participants
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 More than manufacturer's dose	13 Participants

PRIMARY outcome

Timeframe: On arrival to the intensive care unit and hourly thereafter for 6 hours or until extubation, whichever occurs first

The train-of-four ratio will be determined upon arrival to the ICU and every hour for 6 hours or until extubation (whichever is less) and categorized as remaining greater than or equal of 0.9, or declining to \<0.9 (described as "recurrent" neuromuscular blockade)

Outcome measures

Outcome measures
Measure	Cardiac Surgery Patients n=97 Participants Patients undergoing cardiac surgery 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
Duration of Action of Reversal Recurrent train-of-four ratio <0.9	2 Participants
Duration of Action of Reversal Train-of-four ratio >0.9	95 Participants

Adverse Events

Cardiac Surgery Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Bowdle MD, PhD, FASE

University of Washington

Phone: 206-979-0477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place