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

Last updated: September 30, 2024
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

4

Condition

Enuresis

Urinary Incontinence

Genitourinary Prolapse

Treatment

Sugammadex

Neostigmine

Clinical Study ID

NCT05794503
STU-2022-1201
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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, prostatehypertrophy)

  • 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 ofcontraception for 7 days following surgery

Study Design

Total Participants: 235
Treatment Group(s): 2
Primary Treatment: Sugammadex
Phase: 4
Study Start date:
September 11, 2023
Estimated Completion Date:
June 30, 2024

Study Description

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.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390-9068
    United States

    Site Not Available

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