Trial Outcomes & Findings for Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients (NCT NCT03168308)
NCT ID: NCT03168308
Last Updated: 2020-06-04
Results Overview
Hypoxia was defined as an episode of peripheral oxygen saturation (SpO2) \<94% on ≤2 L/min of oxygen by nasal cannula, or a SpO2 \<98% on ≥2 L/min of oxygen, or postoperative SpO2 of ≥5% reduction compared to preoperative values.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
Through patient's stay in the early postoperative period, approximately 1-2 hours.
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
Neostigmine & Glycopyrrolate
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
|
Sugammadex
Patients randomized to receive Sugammadex
Sugammadex: Sugammadex 2 mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
44
|
|
Overall Study
COMPLETED
|
48
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients
Baseline characteristics by cohort
| Measure |
Neostigmine & Glycopyrrolate
n=48 Participants
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
|
Sugammadex
n=44 Participants
Patients randomized to receive Sugammadex
Sugammadex: Sugammadex 2 mg/kg
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through patient's stay in the early postoperative period, approximately 1-2 hours.Hypoxia was defined as an episode of peripheral oxygen saturation (SpO2) \<94% on ≤2 L/min of oxygen by nasal cannula, or a SpO2 \<98% on ≥2 L/min of oxygen, or postoperative SpO2 of ≥5% reduction compared to preoperative values.
Outcome measures
| Measure |
Neostigmine & Glycopyrrolate
n=48 Participants
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
|
Sugammadex
n=44 Participants
Patients randomized to receive Sugammadex
Sugammadex: Sugammadex 2 mg/kg
|
|---|---|---|
|
Number of Hypoxic Episodes
|
1 episode(s)
Interval 0.0 to 2.2
|
0 episode(s)
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: From time of reversal to complete reversal of neuromuscular blockade (train of four ratio ≥0.9), approximately 1 hourThe time from the administration of the blinded reversal syringe until complete reversal of neuromuscular blockade (train of four ratio ≥0.9).
Outcome measures
| Measure |
Neostigmine & Glycopyrrolate
n=48 Participants
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
|
Sugammadex
n=44 Participants
Patients randomized to receive Sugammadex
Sugammadex: Sugammadex 2 mg/kg
|
|---|---|---|
|
Time to Complete Reversal of Neuromuscular Blockade
|
40 minutes
Interval 15.0 to 53.0
|
10 minutes
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: From time of reversal to 80 minutes after arrival in the post-anesthesia care unit, approximately 1-2 hours.To determine if reversal with sugammadex versus neostigmine requires an additional dose of sugammadex rescue after initial reversal of neuromuscular blockade.
Outcome measures
| Measure |
Neostigmine & Glycopyrrolate
n=48 Participants
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
|
Sugammadex
n=44 Participants
Patients randomized to receive Sugammadex
Sugammadex: Sugammadex 2 mg/kg
|
|---|---|---|
|
Number of Participants Who Needed Rescue Sugammadex After Initial Reversal of Neuromuscular Blockade
|
5 Participants
|
0 Participants
|
Adverse Events
Neostigmine & Glycopyrrolate
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugammadex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neostigmine & Glycopyrrolate
n=48 participants at risk
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Neostigmine w/ Glycopyrrolate: Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
|
Sugammadex
n=44 participants at risk
Patients randomized to receive Sugammadex
Sugammadex: Sugammadex 2 mg/kg
|
|---|---|---|
|
Surgical and medical procedures
Reintubation
|
2.1%
1/48 • Number of events 1 • Monitored for 24 hours after surgery end time.
|
0.00%
0/44 • Monitored for 24 hours after surgery end time.
|
|
Injury, poisoning and procedural complications
Critical respiratory or circulatory events
|
2.1%
1/48 • Number of events 1 • Monitored for 24 hours after surgery end time.
|
0.00%
0/44 • Monitored for 24 hours after surgery end time.
|
|
Injury, poisoning and procedural complications
Symptoms of residual neuromuscular blockade
|
10.4%
5/48 • Number of events 5 • Monitored for 24 hours after surgery end time.
|
0.00%
0/44 • Monitored for 24 hours after surgery end time.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place