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Phase 4 N=50 Randomized Double-blind Treatment

Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block

Neuromuscular Blockade

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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