Phase 4
Completed N=50
Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block
Neuromuscular Blockade
Source: ClinicalTrials.gov NCT05545280 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Urine Residual in PACU — 219; 222 ml
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The investigators propose a randomized trial comparing sugammadex and neostigmine for the reversal of neuromuscular blocks induced by rocuronium or vecuronium in adults having general anesthesia with muscular block for noncardiac surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Residual in PACU |
219; 222 | — |
| SECONDARY Number of Participants Who Needed a Urinary Catheter |
5; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent as documented by signature;
- Adults having noncardiac surgery with expected surgery duration ≥ 2 hours;
- General anesthesia requiring endotracheal intubation and neuromuscular block with rocuronium or vecuronium;
- Planned administration of sugammadex or neostigmine for reversal of the neuromuscular block at the end of surgery;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Age ≥ 65 years.
Exclusion Criteria
- Contraindications to the class of drugs under study;
- Preoperative urinary catheter;
- Planned intraoperative insertion of a urinary catheter;
- Neurosurgery (except spine surgery), intraabdominal or retroperitoneal surgeries including but not limited to any kind of laparoscopies, or surgeries in kidneys, ureters or urine bladder.
- Planned postoperative admission to the ICU;
- Severe preoperative hepatic impairment (≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range) or renal impairment (estimated GFR < 30 ml/min or end-stage renal disease requiring scheduled dialysis.);
- History of bladder cancer;
- Presence of a sacral nerve stimulator;
- Current use of anticholinergic medications such as antihistamines, phenothiazines, antidepressants or antipsychotics;
- Urinary tract infections or other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which promote urinary retention;
- Known or suspected neurological conditions such as Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, or Parkinson's disease.
Data sourced from ClinicalTrials.gov (NCT05545280). 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. Informational only — not medical advice.