Clinical trial NCT06948409: NMBA Reversal and Postoperative Urinary Retention
Official title: The Choice of Neuromuscular Blockade Reversal Agent and Its Effects on Postoperative Urinary Retention: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 70000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients at Beth Israel Deaconess Medical Center between September 2016 and January 2024

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.


Eligibility criteria: 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

Primary outcomes:
measure: PACU discharge delay due to POUR
timeFrame: During the admission to the PACU (Perioperative, up to day 1)
Secondary outcomes:
measure: Costs of care
timeFrame: During the patient's hospital stay (Through study completion, an average of 1-2 weeks)
measure: Unplanned hospital visits
timeFrame: Within 7 days after surgery
measure: Time to PACU discharge readiness
timeFrame: During the admission to the PACU (Perioperative, up to day 1)
measure: PACU length of stay
timeFrame: During the admission to the PACU (Perioperative, up to day 1)
measure: Postoperative hospital length of stay
timeFrame: 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)
measure: Urinary catheter use or straight catheterization
timeFrame: Within 3 days after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
name: Maximilian S Schaefer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
name: Luca J Wachtendorf, MD
role: PRINCIPAL_INVESTIGATOR
References: