Trial Outcomes & Findings for Sugammadex and Decreased Time to Extubation (NCT NCT03196167)
NCT ID: NCT03196167
Last Updated: 2022-01-14
Results Overview
The primary outcome of this study aims to test the time to extubation among patients in the cardiothoracic ICU who have undergone isolated CABG.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Up to 2 weeks
Results posted on
2022-01-14
Participant Flow
Patients undergoing AVR, CABG or both were screened meeting preoperative inclusion criteria. Per the study design, elements of exclusion criteria incorporated intraoperative events. Patients were consented prior to the operation room with the understanding that they might be excluded depending on events in the operating room. Patients who screened and consented but did not participate in the study were not considered enrolled. A total of 90 participants were enrolled.
Participant milestones
| Measure |
Sugammadex
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sugammadex and Decreased Time to Extubation
Baseline characteristics by cohort
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
66.0 years
n=7 Participants
|
67.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI
|
29.39 kg/m^2
STANDARD_DEVIATION 4.83 • n=5 Participants
|
29.55 kg/m^2
STANDARD_DEVIATION 4.61 • n=7 Participants
|
29.47 kg/m^2
STANDARD_DEVIATION 4.70 • n=5 Participants
|
|
Smoking
Current
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Smoking
Never
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Smoking
Prior
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Coexisting Medical Conditions
Hypertension
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Coexisting Medical Conditions
COPD
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Coexisting Medical Conditions
TIA/ Stroke
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
HBA1c
|
6.9 percentage of HbA1c
n=5 Participants
|
6.2 percentage of HbA1c
n=7 Participants
|
6.6 percentage of HbA1c
n=5 Participants
|
|
Preoperative Medications
Aspirin
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Preoperative Medications
Plavix
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Preoperative Medications
Angiotensin-converting enzyme inhibitors or Angiotensin II receptor blockers
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Preoperative Medications
Beta blockers
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Preoperative Medications
Statins
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Preoperative Medications
Other antihyperlipidemics
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
ASA Class
</= 3
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
ASA Class
4 or 5
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
STS Surgery Risk Score
|
1.58 %
STANDARD_DEVIATION 0.80 • n=5 Participants
|
1.34 %
STANDARD_DEVIATION .49 • n=7 Participants
|
1.46 %
STANDARD_DEVIATION 0.68 • n=5 Participants
|
|
Type of Surgery
AVR
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Type of Surgery
CABG
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Type of Surgery
CABG plus AVR
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Surgical Factors: Characteristics
Redo sternotomy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Surgical Factors: Characteristics
Off Pump surgery
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Surgical Factors (Time)
Cardiopulmonary Bypass time
|
89.2 Minutes
n=5 Participants
|
85.0 Minutes
n=7 Participants
|
86.0 Minutes
n=5 Participants
|
|
Surgical Factors (Time)
Cross clamp time
|
68.7 Minutes
n=5 Participants
|
63.6 Minutes
n=7 Participants
|
66.0 Minutes
n=5 Participants
|
|
RBCs (Units)
0
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
RBCs (Units)
1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
RBCs (Units)
3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Platelets (units)
0
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Platelets (units)
1
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
FFP (units)
0
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
FFP (units)
1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
FFP (units)
2
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Intraoperative Tidal volume
|
5.3 (ml/kg)
n=5 Participants
|
5.7 (ml/kg)
n=7 Participants
|
5.3 (ml/kg)
n=5 Participants
|
|
Pre-op Hemoglobin (g/dL)
|
13.9 g/dL
n=5 Participants
|
14.6 g/dL
n=7 Participants
|
14.2 g/dL
n=5 Participants
|
|
Creatinine
|
1.0 mg/dL
n=5 Participants
|
.9 mg/dL
n=7 Participants
|
1 mg/dL
n=5 Participants
|
|
Intraoperative opioids
Total intraoperative Fentanyl
|
400.0 mcg
n=5 Participants
|
150.0 mcg
n=7 Participants
|
250.0 mcg
n=5 Participants
|
|
Intraoperative opioids
Total intraoperative Sufentanyl
|
145.6 mcg
n=5 Participants
|
250.5 mcg
n=7 Participants
|
231.8 mcg
n=5 Participants
|
|
Intraoperative Fluids
Intraoperative crystalloids
|
1950.0 ml
n=5 Participants
|
1900.0 ml
n=7 Participants
|
1900.0 ml
n=5 Participants
|
|
Intraoperative Fluids
Intraoperative colloids
|
0.0 ml
n=5 Participants
|
0.0 ml
n=7 Participants
|
0.0 ml
n=5 Participants
|
|
PaO2/FiO2 ratio
|
224.6 ratio
n=5 Participants
|
210.0 ratio
n=7 Participants
|
220.0 ratio
n=5 Participants
|
|
Intraoperative Anesthetic: Rocuronium
|
150.0 mg
n=5 Participants
|
150.0 mg
n=7 Participants
|
150.0 mg
n=5 Participants
|
|
Intraoperative Anesthetic: Midazolam
|
7.0 mg
n=5 Participants
|
7.0 mg
n=7 Participants
|
7.0 mg
n=5 Participants
|
|
Intraoperative Anesthetic: Propofol
|
204.0 mg
n=5 Participants
|
185.0 mg
n=7 Participants
|
196.0 mg
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Of the 90 patients that were included in the study (45 in each group), a total of 68 patients underwent CABG, 13 AVR and 9 combined AVR and CABG.
The primary outcome of this study aims to test the time to extubation among patients in the cardiothoracic ICU who have undergone isolated CABG.
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Time to Extubation
|
126.0 minutes
Interval 84.0 to 274.0
|
219.0 minutes
Interval 121.0 to 323.0
|
SECONDARY outcome
Timeframe: Up to 2 weeksNIF=Negative Inspiratory Force
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Negative Inspiratory Force
|
-33.0 cm per H2O
Interval -40.0 to -27.0
|
-31.0 cm per H2O
Interval -37.0 to -24.0
|
SECONDARY outcome
Timeframe: Upto 2 weeksRapid Shallow Breathing Index
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
RSBI
|
40.0 breaths/min/L
Interval 28.9 to 60.6
|
32.7 breaths/min/L
Interval 24.6 to 46.4
|
SECONDARY outcome
Timeframe: Up to 2 weeksDays in the ICU post opertaitvely
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Length of ICU Stay
|
2 days
Interval 2.0 to 3.0
|
2 days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 weeksLength of Hospital stay after surgery
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Length of Hospital Stay
|
5 Days
Interval 4.0 to 6.0
|
5 Days
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to 2 weeksAny dysrhythmia after surgery in patients without history of dysrhythmia
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
New Dysrhythmia
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeksChange in renal function was defined as Creatinine elevation \>0.5 mg/dl
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Change in Renal Function
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: There was not statistically significant difference between the 2 groups. (p=1.0)
Postoperative congestive heart failure
Outcome measures
| Measure |
Sugammadex
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Sugammadex: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
Placebo
n=45 Participants
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
Placebo: The one time intravenous administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
|
|---|---|---|
|
Postoperative CHF
|
0 Participants
|
1 Participants
|
Adverse Events
Sugammadex
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugammadex
n=45 participants at risk
Patients received 2 mg/kg Sugammadex intravenously once in the postoperative period in a blinded fashion.
|
Placebo
n=45 participants at risk
Patients received placebo intravenously once in the postoperative period in a blinded fashion.
|
|---|---|---|
|
Renal and urinary disorders
postoperative creatinine rise greater than 0.5 mg/dl
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded during the hospitalization, an average of 5 days
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded during the hospitalization, an average of 5 days
|
|
Cardiac disorders
postoperative atrial fibrillation
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded during the hospitalization, an average of 5 days
|
13.3%
6/45 • Number of events 6 • Adverse events were recorded during the hospitalization, an average of 5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place