NMBA Reversal and Postoperative Urinary Retention

January 21, 2026 updated by: Luca J Wachtendorf, MD, Beth Israel Deaconess Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 [%]).
During the admission to the PACU (Perioperative, up to day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
During the patient's hospital stay (Through study completion, an average of 1-2 weeks)
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.
Within 7 days after surgery
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.
During the admission to the PACU (Perioperative, up to day 1)
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.
During the admission to the PACU (Perioperative, up to day 1)
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.
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
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.
Within 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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