Phase 4
N=50
Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block
Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT05545280 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Urine Residual in PACU — 219; 222 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Neostigmine with glycopyrrolate (Drug); Sugammadex (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Residual in PACU |
219; 222 | — |
| SECONDARY Number of Participants Who Needed a Urinary Catheter |
5; 2 | — |
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.
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.