Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial

22-745

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.

2023-07-31

2024-12-01

2025-02-01

Recruiting

Early phase I

286

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 286, 'type': 'ESTIMATED'}}

2023-12-28