Trial Outcomes & Findings for Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency (NCT NCT02860507)
NCT ID: NCT02860507
Last Updated: 2019-04-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
through start of next surgery, average of 2 hours
Results posted on
2019-04-12
Participant Flow
Participant milestones
| Measure |
Neostigmine + Glycopyrrolate
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Neostigmine
Glycopyrrolate
|
Sugammadex
Sugammadex 4mg/kg
sugammadex
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
Baseline characteristics by cohort
| Measure |
Neostigmine + Glycopyrrolate
n=25 Participants
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Neostigmine
Glycopyrrolate
|
Sugammadex
n=25 Participants
Sugammadex 4mg/kg
sugammadex
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
45.6 Years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
45.2 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 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
|
|
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
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through start of next surgery, average of 2 hoursOutcome measures
| Measure |
Neostigmine + Glycopyrrolate
n=25 Participants
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Neostigmine
Glycopyrrolate
|
Sugammadex
n=25 Participants
Sugammadex 4mg/kg
sugammadex
|
|---|---|---|
|
Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
|
49.7 Minutes
Standard Deviation 16.18
|
49.45 Minutes
Standard Deviation 16.67
|
SECONDARY outcome
Timeframe: through discharge from hospital, average of 72 hoursOutcome measures
| Measure |
Neostigmine + Glycopyrrolate
n=25 Participants
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Neostigmine
Glycopyrrolate
|
Sugammadex
n=25 Participants
Sugammadex 4mg/kg
sugammadex
|
|---|---|---|
|
Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
|
8 Participants
|
10 Participants
|
Adverse Events
Neostigmine + Glycopyrrolate
Serious events: 0 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
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chadwick Neal / Medical Affairs Director
Merck Pharmaceuticals
Phone: 2056010605
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place