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NCT Number: NCT06948409

NMBA Reversal and Postoperative Urinary Retention

In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients
  • Non-urinary system surgery
  • General anesthesia
  • Use of rocuronium or vecuronium for neuromuscular blockade
  • Neuromuscular blockade reversal with sugammadex or neostigmine (with atropine and/or glycopyrrolate)
  • Postoperative admission to the post-anesthesia care unit (PACU)

Exclusion criteria

  • American Society of Anesthesiologists (ASA) physical status ≥ V
  • Emergency reversal with sugammadex (≥ 16 mg/kg of sugammadex)
  • Presence of foley or suprapubic catheter before or after the procedure
  • Prior history of bladder resection surgery
  • Observations with missing data for pre-specified confounding variables

Treatment and study plan

Choice of reversal agent (sugammadex or neostigmine [with muscaranic antagonist])

Drug

The use of sugammadex or neostigmine (in co-administration with muscarinic antagonist) will be compared. The muscarinic antagonists that will be considered are atropine and glycopyrrolate.

Primary outcomes

  1. PACU discharge delay due to POUR

    Time frame: During the admission to the PACU (Perioperative, up to day 1)

    The primary outcome, post-anesthesia care unit (PACU) discharge delay due to postoperative urinary (POUR), will be defined as a documented delay in PACU discharge due to the inability to void. The PACU nurses or physicians responsible for immediate postoperative care routinely document these delays. Documentation about delays is required before a patient is discharged from the PACU. Within the individual categories "renal", "urinary", and "other", the investigators will search through all free text entries related to urinary retention. The study team will perform this review, and potential misspellings or synonyms will be identified and accounted for during the review process. The final primary endpoint, PACU discharge delay due to POUR, will be binary, and the endpoint data will be reported as frequency (total number [n] and proportion [%]).

Secondary outcomes

  1. Costs of care

    Time frame: During the patient's hospital stay (Through study completion, an average of 1-2 weeks)

    Costs of care will be assessed using the hospital's cost calculations from an internal financial tracking system. This endpoint will include direct hospital costs, defined as variable and fixed costs directly associated with patient-care-related activities. To maintain the sensitive nature of cost data, the investigators will match the outcome data with data from the Healthcare Cost and Utilization Project-National Inpatient Sample (HCUP-NIS). Differences in total perioperative healthcare-associated costs in US-dollars between patients receiving different reversal strategies will be reported. While direct hospital cost data from the hospital network will serve as the outcome for linear regression analyses, the HCUP-NIS only provides total hospital costs. Thus, data will be matched with the HCUP-NIS data, and regression estimates from the study's dataset will subsequently be translated to obtain changes in total costs.

  2. Unplanned hospital visits

    Time frame: Within 7 days after surgery

    Unplanned hospital visits within 7 days after ambulatory surgery will be defined as unplanned admission to the hospital after surgery, emergency department (ED) visits, or readmission to the hospital. Only patients undergoing ambulatory procedures will be included in this analysis. International Classification of Diseases, 10th Revision, Clinical Modification diagnostic codes, and notes related to the ED or readmission will be used to define unplanned hospital visits. Only the admission directly following the ambulatory procedure will be considered. If a patient undergoes more than one ambulatory procedure within 7 days before an inpatient admission, the procedure closest to the unplanned hospital visit will be identified as the index case.

  3. Time to PACU discharge readiness

    Time frame: During the admission to the PACU (Perioperative, up to day 1)

    Time to PACU discharge readiness will be defined as the time from arrival to the PACU until a nurse has cleared the patient to be ready for discharge, measured in minutes. This outcome offers an accurate estimate of patient recovery independent from institutional factors such as bed availability or staffing, as opposed to the overall PACU length of stay.

  4. PACU length of stay

    Time frame: During the admission to the PACU (Perioperative, up to day 1)

    PACU length of stay, measured in minutes, is the time between arrival until discharge from the PACU following surgery. In contrast to PACU discharge readiness, this endpoint considers the total time a patient spent in the PACU and correlates with the use of resources used (and subsequently costs) for post-anesthetic care for a patient.

  5. Postoperative hospital length of stay

    Time frame: During the patient's hospital stay, defined as the time between surgery and day of discharge (Through study completion, an average of 1-2 weeks)

    Postoperative hospital length of stay will be defined as the time between surgery and discharge during the index hospitalization, measured in days. Patients undergoing ambulatory surgery will not be considered for this analysis.

  6. Urinary catheter use or straight catheterization

    Time frame: Within 3 days after surgery

    The use of urinary catheters or straight catheterization within 3 days after surgery will be assessed. Patients undergoing ambulatory surgery will not be considered for this analysis.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

The Choice of Neuromuscular Blockade Reversal Agent and Its Effects on Postoperative Urinary Retention: A Retrospective Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Jan 23, 2026

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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