Trial Outcomes & Findings for Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo (NCT NCT05801679)
NCT ID: NCT05801679
Last Updated: 2026-05-04
Results Overview
Will compare the difference in the number of subjects who receive sugammadex and meet the STS 6-hour extubation criteria from the end of surgery vs. those that do not receive neuromuscular blockade reversal. The Society of Thoracic Surgery defines early extubation as extubation within six hours of completion of cardiac surgery and uses this as a reportable benchmark.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
within 6 hours of end of surgery
Results posted on
2026-05-04
Participant Flow
Patients undergoing elective or urgent open cardiac surgery on cardiopulmonary bypass were consented for participation 2023 through 2025. Participants were recruited from the Cardiac Surgical Clinic at Endeavor Health and seen in the ICU.
Participant milestones
| Measure |
Sugammadex
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
|
Overall Study
Randomized
|
33
|
35
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo
Baseline characteristics by cohort
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=54 Participants
|
63 years
n=60 Participants
|
64 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
16 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=54 Participants
|
22 Participants
n=60 Participants
|
48 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
25 Participants
n=54 Participants
|
21 Participants
n=60 Participants
|
46 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic/Latino
|
1 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=54 Participants
|
32 participants
n=60 Participants
|
64 participants
n=114 Participants
|
|
Body Mass Index (BMI)
|
28.9 kg/m2
STANDARD_DEVIATION 6.5 • n=54 Participants
|
28.6 kg/m2
STANDARD_DEVIATION 5.3 • n=60 Participants
|
28.8 kg/m2
STANDARD_DEVIATION 5.9 • n=114 Participants
|
|
System Comorbidities
Endocrinologic
|
11 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
21 Participants
n=114 Participants
|
|
ASA Status
2
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
ASA Status
3
|
11 Participants
n=54 Participants
|
14 Participants
n=60 Participants
|
25 Participants
n=114 Participants
|
|
ASA Status
4
|
21 Participants
n=54 Participants
|
17 Participants
n=60 Participants
|
38 Participants
n=114 Participants
|
|
System Comorbidities
Liver
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
System Comorbidities
Kidney
|
2 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
System Comorbidities
Neurologic
|
1 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
System Comorbidities
Respiratory
|
11 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
20 Participants
n=114 Participants
|
|
System Comorbidities
Heart
|
31 Participants
n=54 Participants
|
32 Participants
n=60 Participants
|
63 Participants
n=114 Participants
|
|
System Comorbidities
Any comorbidity
|
32 Participants
n=54 Participants
|
32 Participants
n=60 Participants
|
64 Participants
n=114 Participants
|
|
Surgery Type
Elective
|
26 Participants
n=54 Participants
|
28 Participants
n=60 Participants
|
54 Participants
n=114 Participants
|
|
Surgery Type
Urgent
|
6 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
|
BMI
|
26.9 kg/m2
n=54 Participants
|
28.9 kg/m2
n=60 Participants
|
27.7 kg/m2
n=114 Participants
|
PRIMARY outcome
Timeframe: within 6 hours of end of surgeryWill compare the difference in the number of subjects who receive sugammadex and meet the STS 6-hour extubation criteria from the end of surgery vs. those that do not receive neuromuscular blockade reversal. The Society of Thoracic Surgery defines early extubation as extubation within six hours of completion of cardiac surgery and uses this as a reportable benchmark.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria
|
31 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)Time to first extubation from end of surgery in each group will be recorded.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Time to First Extubation
|
3.55 hours
Standard Deviation 3.55
|
3.34 hours
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)Time to first extubation from end of surgery in each group will be recorded.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Time to First Extubation
|
2.80 hours
Interval 2.27 to 3.47
|
3.19 hours
Interval 2.58 to 3.82
|
SECONDARY outcome
Timeframe: At time of extubationThe final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9. In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Final Train-of-Four Ratio
|
1.01 ratio
Standard Deviation 0.06
|
0.68 ratio
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: At time of extubationThe final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9 In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Final Train-of-Four Ratio
|
1.00 ratio
Interval 0.96 to 1.04
|
0.80 ratio
Interval 0.46 to 0.97
|
SECONDARY outcome
Timeframe: From time of postoperative ICU admission to time of ICU dischargeICU length of stay (hours) in each group will be recorded.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
ICU Length of Stay
|
3.57 hours
Standard Deviation 4.32
|
3.18 hours
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: From time of postoperative ICU admission to time of ICU dischargeICU length of stay (hours) in each group will be recorded.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
ICU Length of Stay
|
2.18 hours
Interval 1.57 to 3.93
|
2.26 hours
Interval 2.03 to 3.27
|
SECONDARY outcome
Timeframe: From time of hospital admission to time of hospital dischargeHospital length of stay (days) in each group will be recorded.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Hospital Length of Stay
|
7.65 days
Standard Deviation 6.56
|
5.88 days
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: From time of hospital admission to time of hospital dischargeHospital length of stay (days) in each group will be recorded.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Hospital Length of Stay
|
5.32 days
Interval 4.34 to 8.0
|
4.42 days
Interval 4.27 to 5.41
|
SECONDARY outcome
Timeframe: up to 1 weekThe incidence of reintubation post-extubation in each group will be collected during the current hospital stay.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Incidence of Reintubation Post-extubation
No
|
31 Participants
|
32 Participants
|
|
Incidence of Reintubation Post-extubation
Yes
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 1 weekThe incidence of post-extubation pneumonia in each group will be collected during the current hospital stay
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Incidence of Post-extubation Pneumonia
No
|
30 Participants
|
31 Participants
|
|
Incidence of Post-extubation Pneumonia
Yes
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Average of 6 hour intervals over first 24 hours post-operativelyPost-extubation hypoxemic episodes were defined according to the Berlin criteria where PaO2/FiO2 ratios were approximated using previously validated SpO2/FiO2 ratios every 6 hours for 24 hours post-extubation. SpO2/FiO2 \< 235 corresponded to moderate to severe hypoxemia and 235-315 corresponded to mild hypoxemia. Reported ratio values were calculated as the average of data collected (every 6 hours) during the 24-hour period post-extubation.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Post-Extubation Hypoxemia
|
353.39 Average SPO2/FiO2 ratio
Standard Deviation 71.91
|
373.04 Average SPO2/FiO2 ratio
Standard Deviation 57.99
|
SECONDARY outcome
Timeframe: Average of 6 hour intervals over first 24 hours post-operativelyPost-extubation hypoxemic episodes were defined according to the Berlin criteria where PaO2/FiO2 ratios were approximated using previously validated SpO2/FiO2 ratios every 6 hours for 24 hours post-extubation. SpO2/FiO2 \< 235 corresponded to moderate to severe hypoxemia and 235-315 corresponded to mild hypoxemia. Reported ratio values were calculated as the average of data collected (every 6 hours) during the 24-hour period post-extubation.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Post-Extubation Hypoxemia
|
364.35 Average SPO2/FiO2 ratio
Interval 312.77 to 405.48
|
386.90 Average SPO2/FiO2 ratio
Interval 328.92 to 419.52
|
SECONDARY outcome
Timeframe: 24 hours post-operativelyHypoxemia information regarding the first 24 hours post operatively was retrospectively collected post-discharge and was defined in accordance with the Berlin criteria.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Post-Extubation Hypoxemia
Experienced Any Hypoxemia Over 24 Hours
|
22 participants
|
21 participants
|
|
Post-Extubation Hypoxemia
Required >50% O2 For More Than an Hour (Within 24 Hours)
|
2 participants
|
1 participants
|
|
Post-Extubation Hypoxemia
Required BiPAP
|
4 participants
|
1 participants
|
|
Post-Extubation Hypoxemia
Required HFNC
|
1 participants
|
1 participants
|
|
Post-Extubation Hypoxemia
Required Either BiPAP or HFNC
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Within first 24 hours of ICU length of stayThe nursing perception questionnaire of cardiac surgical subjects' ICU quality of recovery within first 24 hours of ICU length of stay will be collected. (A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4= Somewhat satisfied, 5= Very satisfied)
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery
|
4.34 units on a scale
Standard Deviation 0.76
|
4.06 units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Within first 24 hours of ICU length of stayThe nursing perception questionnaire of cardiac surgical subjects' ICU quality of recovery within first 24 hours of ICU length of stay will be collected. (A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4= Somewhat satisfied, 5= Very satisfied)
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery
|
4 units on a scale
Interval 4.0 to 5.0
|
4 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: At extubationThe number of participants that achieved a qTOFR greater than or equal to 0.9 was compared between the sugammadex and placebo arms. In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
Outcome measures
| Measure |
Sugammadex
n=32 Participants
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 Participants
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9
≥0.9
|
32 Participants
|
12 Participants
|
|
Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9
<0.9
|
0 Participants
|
20 Participants
|
Adverse Events
Sugammadex
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugammadex
n=32 participants at risk
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 participants at risk
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
General disorders
Increased Level of Care Required
|
3.1%
1/32 • Number of events 1 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
0.00%
0/32 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Re-intubation, mechanical ventilation, iNO
|
3.1%
1/32 • Number of events 1 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
0.00%
0/32 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
|
Cardiac disorders
Pericardial effusion and concern for cardiac tamponade
|
0.00%
0/32 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
3.1%
1/32 • Number of events 1 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
|
Vascular disorders
bilateral pulmonary embolism and deep vein thrombosis with thrombectomy
|
3.1%
1/32 • Number of events 2 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
0.00%
0/32 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
acute hypoxemic respiratory insufficiency requiring thoracocentesis
|
0.00%
0/32 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
3.1%
1/32 • Number of events 1 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
Other adverse events
| Measure |
Sugammadex
n=32 participants at risk
Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
Placebo
n=32 participants at risk
Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4).
Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded.
|
|---|---|---|
|
Vascular disorders
Iliofemoral thrombectomy
|
3.1%
1/32 • Number of events 1 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
0.00%
0/32 • From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place