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NCT05794503 · ClinicalTrials.gov registry record · Phase 4
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 235
- Enrollment target
NCT05794503: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT05794503 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 235 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05794503, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 235 participants
- Enrollment target
Study Summary
This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.
Primary Outcome
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
Interventions
- DRUG Sugammadex
- DRUG Neostigmine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2023-09-11 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 4 |
What the finished NCT05794503 record still lists
NCT05794503 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Sugammadex is the first listed.
NCT05794503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05794503 about?
NCT05794503 is a clinical study titled "Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex". This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induce...
What is the current status of trial NCT05794503?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 235 participants. The study started on 2023-09-11. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT05794503?
The interventions under investigation include: Sugammadex (DRUG), Neostigmine (DRUG).
Who is sponsoring clinical trial NCT05794503?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05794503's enrollment target sits among peer trials
235 369th of 2000 higher than 1,632 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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