Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

STU-2022-1201

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.

2023-09-11

2026-09-01

2027-09-01

Recruiting

Early phase I

230

Inclusion Criteria: * 18-80 years old * Undergoing laparoscopic cholecystectomy * Anticipated surgical duration \<2 hours * ASA physical status classification 1-3 * Willing and able to consent in English or Spanish * No personal history of neuromuscular disease Exclusion Criteria: * Preoperative urinary catheter * History of problems with urination * Current use of anticholinergic medications (e.g., antihistamines, phenothiazines, antidepressants, antipsychotics) * Current UTI or urogenital problem (incontinence, known bladder retention, prostate hypertrophy) * Planned intraoperative insertion of a urinary catheter * ESRD (GRF \<30 mL/min) * ESLD (AST or ALT \> 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single site, randomized, controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 230, 'type': 'ESTIMATED'}}

2023-11-07