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Trial Outcomes & Findings for Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex (NCT NCT05794503)

NCT ID: NCT05794503

Last Updated: 2024-10-09

Results Overview

Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. Need for insertion of Foley catheter or straight catheter

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

235 participants

Primary outcome timeframe

In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.

Results posted on

2024-10-09

Participant Flow

Participant milestones

Participant milestones
Measure
Neostigmine
One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Sugammadex
One type of Neuromuscular Blockade Reversal Drug Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
Overall Study
STARTED
117
118
Overall Study
COMPLETED
112
118
Overall Study
NOT COMPLETED
5
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Neostigmine
One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Sugammadex
One type of Neuromuscular Blockade Reversal Drug Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
Overall Study
Operation Cancelled
2
0
Overall Study
Received Neostigmine + Sugammadex
2
0
Overall Study
Protocol Violation
1
0

Baseline Characteristics

Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Neostigmine
n=112 Participants
One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Sugammadex
n=118 Participants
One type of Neuromuscular Blockade Reversal Drug Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
Total
n=230 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
106 Participants
n=5 Participants
106 Participants
n=7 Participants
212 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
12 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex: Female, Male
Female
87 Participants
n=5 Participants
89 Participants
n=7 Participants
176 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
29 Participants
n=7 Participants
54 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
103 Participants
n=5 Participants
99 Participants
n=7 Participants
202 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
19 Participants
n=7 Participants
28 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
112 participants
n=5 Participants
118 participants
n=7 Participants
230 participants
n=5 Participants

PRIMARY outcome

Timeframe: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.

Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. Need for insertion of Foley catheter or straight catheter

Outcome measures

Outcome measures
Measure
Neostigmine
n=112 Participants
One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Sugammadex
n=118 Participants
One type of Neuromuscular Blockade Reversal Drug Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups
20 Participants
6 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

Tiffany Moon, MD

UT Southwestern Medical Center

Phone: (214) 648-6400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place