Phase 4
N=235
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
Urinary Retention Postoperative · Laparoscopic Cholecystectomy · Neuromuscular Blockade · Sugammadex · Neostigmine
Bottom Line
View on ClinicalTrials.gov: NCT05794503 ↗Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups — 20; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Neostigmine (Drug); Sugammadex (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups |
20; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18-80 years old
- Undergoing laparoscopic cholecystectomy
- Anticipated surgical duration 3x reference range)
- Planned postoperative intubation/ventilation or admission to ICU
- Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
- Pregnant or nursing women
- "Stat" (emergent) cases
- Known or suspected neurological condition (e.g., Alzheimer's, h/o of stroke, multiple sclerosis, Parkinson's)
- Patients on toremifene (a selective estrogen receptor modulator)
- Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery
Data sourced from ClinicalTrials.gov (NCT05794503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.