Trial Outcomes & Findings for Sugammadex vs Placebo to Prevent Residual Neuromuscular Block (NCT NCT02728726)

Last Updated: 2022-07-14

Results Overview

The number of subjects who have a MV as defined as \[MV \<80% MV predicted (MVPRED) based on Body Surface Area\]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

260 participants

Primary outcome timeframe

15---30 minutes after Post-anesthesia care unit (PACU) arrival

Results posted on

2022-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Sugammadex Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated. Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Placebo Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated. Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.
Overall Study STARTED	127	133
Overall Study COMPLETED	127	133
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex n=127 Participants Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated. Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Placebo n=133 Participants Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated. Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Total n=260 Participants Total of all reporting groups
Age, Continuous	53.65 years STANDARD_DEVIATION 16.74 • n=127 Participants	52.13 years STANDARD_DEVIATION 16.07 • n=133 Participants	52.87 years STANDARD_DEVIATION 16.39 • n=260 Participants
Sex: Female, Male Female	45 Participants n=127 Participants	37 Participants n=133 Participants	82 Participants n=260 Participants
Sex: Female, Male Male	82 Participants n=127 Participants	96 Participants n=133 Participants	178 Participants n=260 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=70 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=74 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=144 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized Asian	0 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	2 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	2 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized Native Hawiian or Other Pacific Islander	0 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized Black or African American	5 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	4 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	9 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized White	61 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	67 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	128 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	1 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	2 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized More than one race	0 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Race/Ethnicity, Customized Unknown	3 Participants n=127 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	0 Participants n=133 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.	3 Participants n=260 Participants • Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option.
Region of Enrollment United States	127 participants n=127 Participants	133 participants n=133 Participants	260 participants n=260 Participants

PRIMARY outcome

Timeframe: 15---30 minutes after Post-anesthesia care unit (PACU) arrival

Outcome measures

Outcome measures
Measure	Sugammadex n=62 Participants Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated. Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Placebo n=54 Participants Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated. Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.
Decreased Minute Ventilation (MV)	20 Participants	26 Participants

PRIMARY outcome

Timeframe: 15---30 minutes after Post-anesthesia care unit (PACU) arrival

The number of subjects who have an average MV \<80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.

Outcome measures

Outcome measures
Measure	Sugammadex n=62 Participants Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated. Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Placebo n=54 Participants Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated. Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.
Decreased Average Minute Ventilation (MV)	20 Participants	26 Participants

SECONDARY outcome

Timeframe: upon PACU discharge, approximately 8 hours

The number of subjects to have a normal TOF ratio (\>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)

Outcome measures

Outcome measures
Measure	Sugammadex n=62 Participants Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated. Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Placebo n=54 Participants Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated. Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.
Train of Four (TOF) Ratio	42 Participants	29 Participants

Adverse Events

Sugammadex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sugammadex n=127 participants at risk Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated. Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.	Placebo n=133 participants at risk Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated. Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated.
Cardiac disorders Cardiac Catherization post surgery - Stent placed	0.00% 0/127 • Adverse Events were collected from baseline to end of study (discharged from the recovery room), approximately 8 hours	0.75% 1/133 • Adverse Events were collected from baseline to end of study (discharged from the recovery room), approximately 8 hours
Respiratory, thoracic and mediastinal disorders Extended intubation	0.00% 0/127 • Adverse Events were collected from baseline to end of study (discharged from the recovery room), approximately 8 hours	0.75% 1/133 • Adverse Events were collected from baseline to end of study (discharged from the recovery room), approximately 8 hours

Additional Information

J. Ross Renew, M.D.

Mayo Clinic

Phone: 904-956-3328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place