Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex

Study Overview
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Brief Summary
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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.

Detailed Description
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Objective: To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy. Hypothesis: Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.

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

Conditions
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Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade, Sugammadex, Neostigmine, Neuromuscular Blocking Agents, Physiological Effects of Drugs

Intervention / Treatment
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* Drug: Neostigmine
* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single site, randomized, controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine<br>One type of Neuromuscular Blockade Reversal Drug | Drug: Neostigmine<br>* Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.<br>|
| Active Comparator: Sugammadex<br>One type of Neuromuscular Blockade Reversal Drug | Drug: Sugammadex<br>* Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups. |  | 18 months |