NMBA Reversal and Postoperative Urinary Retention

NCT06948409 | Active Not Recruiting FDA Drug

• 2 other identifiers: 2025P000474MISP #102761
• Study Type: observational
• Target: 70,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blocking Agents; Urinary Retention After Procedure; Urinary Retention Postoperative; Neuromuscular Blockade Reversal Agent; Neuromuscular Blockade; Costs; Atropine; Sugammadex; Glycopyrrolate; Neostigmine; Anesthesia

Keywords

Neuromuscular Blockade; Neuromuscular Blocking Agents; Sugammadex; Neuromuscular Blockade reversal agent; Urinary Retention Postoperative; Urinary Retention; Urinary Retention After Procedure; Costs; Neostigmine; Anesthesia; Atropine; Glycopyrrolate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Costs of care

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

• Unplanned hospital visits

  Within 7 days after surgery

• Time to PACU discharge readiness

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

• PACU length of stay

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

• Postoperative hospital length of stay

  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)

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Resident and Clinical Fellow, Co-Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 29, 2025
• Study Start: June 8, 2025
• Primary Completion: August 31, 2025
• Study Completion: June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)