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NCT Number: NCT05794503

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine

Drug

Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.

Sugammadex

Drug

Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Primary outcomes

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

    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.

    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:

    • Inability to spontaneously urinate and a bladder volume ≥ 300 mL
    • Postvoid residual > 150 mL
    • Need for insertion of Foley catheter or straight catheter

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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