Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block

NCT05545280 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 22-745
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a randomized trial comparing sugammadex and neostigmine for the reversal of neuromuscular blocks induced by rocuronium or vecuronium in adults having general anesthesia with muscular block for noncardiac surgery.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Urine Residual in PACU

  The primary outcome of urinary retention is assessed by post-void bladder volume.

  1 hour after surgery, which started from out of operation room

Secondary Outcomes (1)

• Number of Participants Who Needed a Urinary Catheter

  within 24 hours after out of operation room

Other Outcomes (1)

• Participants Having Urinary Tract Infections

  during postoperative hospital stay, which from out of operation room to discharge from the hospital, an average of 1 week

Study Arms (2)

Neostigmine

ACTIVE COMPARATOR

Reversal of Neuromuscular Block by Neostigmine.

Drug: Neostigmine with glycopyrrolate

Sugammadex

ACTIVE COMPARATOR

Reversal of Neuromuscular Block by Sugammadex.

Drug: Sugammadex

Interventions

Neostigmine with glycopyrrolate DRUG

Administration by intravenous infusion

Neostigmine

Sugammadex DRUG

Administration by intravenous infusion

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature;
• Adults having noncardiac surgery with expected surgery duration ≥ 2 hours;
• General anesthesia requiring endotracheal intubation and neuromuscular block with rocuronium or vecuronium;
• Planned administration of sugammadex or neostigmine for reversal of the neuromuscular block at the end of surgery;
• American Society of Anesthesiologists (ASA) physical status 1-3;
• Age ≥ 65 years.

You may not qualify if:

• Contraindications to the class of drugs under study;
• Preoperative urinary catheter;
• Planned intraoperative insertion of a urinary catheter;
• Neurosurgery (except spine surgery), intraabdominal or retroperitoneal surgeries including but not limited to any kind of laparoscopies, or surgeries in kidneys, ureters or urine bladder.
• Planned postoperative admission to the ICU;
• Severe preoperative hepatic impairment (≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range) or renal impairment (estimated GFR \< 30 ml/min or end-stage renal disease requiring scheduled dialysis.);
• History of bladder cancer;
• Presence of a sacral nerve stimulator;
• Current use of anticholinergic medications such as antihistamines, phenothiazines, antidepressants or antipsychotics;
• Urinary tract infections or other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which promote urinary retention;
• Known or suspected neurological conditions such as Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, or Parkinson's disease.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Kurt Ruetzler, MD
• Organization: Cleveland Clinic Foundation

RUETZLK@ccf.org

216 636-0561

Study Officials

• Kurt Ruetzler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 19, 2022
• Study Start: December 1, 2023
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Locations

US (1)