Adults 18 to 80, any sex, with Urinary Retention Postoperative or Laparoscopic Cholecystectomy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine GroupsPrimary· 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
Group
Value
95% CI
Neostigmine
20
Sugammadex
6
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 9 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05794503.