NMBA Reversal and Postoperative Urinary Retention

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia; Neuromuscular Blockade; Costs; Urinary Retention Postoperative; Neuromuscular Blockade Reversal Agent; Sugammadex; Neostigmine; Neuromuscular Blocking Agents; Glycopyrrolate; Urinary Retention After Procedure; Atropine
• Intervention / Treatment: Drug: Choice of reversal agent (sugammadex or neostigmine [with muscaranic antagonist])

• Study Type: Observational
• Enrollment (Estimated): 70000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients at Beth Israel Deaconess Medical Center between September 2016 and January 2024

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU discharge delay due to POUR	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 [%]).	During the admission to the PACU (Perioperative, up to day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs of care	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.	During the patient's hospital stay (Through study completion, an average of 1-2 weeks)
Unplanned hospital visits	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.	Within 7 days after surgery
Time to PACU discharge readiness	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.	During the admission to the PACU (Perioperative, up to day 1)
PACU length of stay	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.	During the admission to the PACU (Perioperative, up to day 1)
Postoperative hospital length of stay	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.	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)
Urinary catheter use or straight catheterization	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.	Within 3 days after surgery

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Maximilian S Schaefer, MD, PhD, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center; Principal Investigator: Luca J Wachtendorf, MD, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2025
• Primary Completion (Actual): August 31, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Anesthesia; Urinary Retention; Costs; Neuromuscular Blockade; Sugammadex; Atropine; Neostigmine; Neuromuscular Blocking Agents; Glycopyrrolate; Neuromuscular Blockade reversal agent; Urinary Retention Postoperative; Urinary Retention After Procedure
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention; Organic Chemicals; Carbohydrates; Polycyclic Compounds; Amines; Polysaccharides; Macrocyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Dextrins; Starch; Glucans; Neostigmine; Sugammadex
• Other Study ID Numbers: 2025P000474; MISP #102761 (Other Grant/Funding Number: MERCK SHARP & DOHME LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Due to the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject research and confidentiality may be sent to Maximilian S. Schaefer at msschaef@bidmc.harvard.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes