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

University of Texas Southwestern Medical Center235 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

235

Conditions

Urinary Retention Postoperative Laparoscopic Cholecystectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups

Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. Need for insertion of Foley catheter or straight catheter

Time frame: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.