Trial Outcomes & Findings for Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block (NCT NCT05545280)
NCT ID: NCT05545280
Last Updated: 2025-02-10
Results Overview
The primary outcome of urinary retention is assessed by post-void bladder volume.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
1 hour after surgery, which started from out of operation room
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Neostigmine
Reversal of Neuromuscular Block by Neostigmine.
Neostigmine with glycopyrrolate: Administration by intravenous infusion
|
Sugammadex
Reversal of Neuromuscular Block by Sugammadex.
Sugammadex: Administration by intravenous infusion
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
27
|
|
Overall Study
COMPLETED
|
23
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block
Baseline characteristics by cohort
| Measure |
Neostigmine
n=23 Participants
Reversal of Neuromuscular Block by Neostigmine.
Neostigmine with glycopyrrolate: Administration by intravenous infusion
|
Sugammadex
n=27 Participants
Reversal of Neuromuscular Block by Sugammadex.
Sugammadex: Administration by intravenous infusion
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
72.1 years
STANDARD_DEVIATION 7 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ASA score
1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ASA score
2
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
ASA score
3
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
ASA score
unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI
|
26.1 kg/m2
n=5 Participants
|
28.6 kg/m2
n=7 Participants
|
27 kg/m2
n=5 Participants
|
|
pulmonary disease
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
cardiac disease
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
kidney disease
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
neurological disease
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
previous surgery
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Metabolic equivalent
2.0
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Metabolic equivalent
3.0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Metabolic equivalent
3.5
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Metabolic equivalent
4.0
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Metabolic equivalent
>4
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Substance abuse-illegal drug use
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Substance abuse -alcohol abuse
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour after surgery, which started from out of operation roomPopulation: A total of 50 patients were included in data analysis based on the modified intent-to-treat rule
The primary outcome of urinary retention is assessed by post-void bladder volume.
Outcome measures
| Measure |
Neostigmine
n=23 Participants
Reversal of Neuromuscular Block by Neostigmine.
Neostigmine with glycopyrrolate: Administration by intravenous infusion
|
Sugammadex
n=27 Participants
Reversal of Neuromuscular Block by Sugammadex.
Sugammadex: Administration by intravenous infusion
|
|---|---|---|
|
Urine Residual in PACU
|
219 ml
Interval 141.0 to 329.0
|
222 ml
Interval 68.0 to 361.0
|
SECONDARY outcome
Timeframe: within 24 hours after out of operation roomparticipants who needed a urinary catheter within 24 hours after surgery
Outcome measures
| Measure |
Neostigmine
n=23 Participants
Reversal of Neuromuscular Block by Neostigmine.
Neostigmine with glycopyrrolate: Administration by intravenous infusion
|
Sugammadex
n=27 Participants
Reversal of Neuromuscular Block by Sugammadex.
Sugammadex: Administration by intravenous infusion
|
|---|---|---|
|
Number of Participants Who Needed a Urinary Catheter
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during postoperative hospital stay, which from out of operation room to discharge from the hospital, an average of 1 weekpatients having urinary tract infections during the hospitalization
Outcome measures
| Measure |
Neostigmine
n=23 Participants
Reversal of Neuromuscular Block by Neostigmine.
Neostigmine with glycopyrrolate: Administration by intravenous infusion
|
Sugammadex
n=27 Participants
Reversal of Neuromuscular Block by Sugammadex.
Sugammadex: Administration by intravenous infusion
|
|---|---|---|
|
Participants Having Urinary Tract Infections
|
0 Participants
|
0 Participants
|
Adverse Events
Neostigmine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place