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Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine or Sugammadex

Primary Purpose

Neuromuscular Blockade

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Neostigmine with glycopyrrolate
Sugammadex
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Blockade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed Consent as documented by signature
  • Adults having orthopedic surgery on the lower extremity 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

Exclusion Criteria:

  • Contraindications to the class of drugs under study
  • Preoperative urinary catheter
  • Planned intraoperative insertion of a urinary catheter
  • 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

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neostigmine

Sugammadex

Arm Description

Reversal of Neuromuscular Block by Neostigmine.

Reversal of Neuromuscular Block by Sugammadex.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications related to urinary retention
Complications of interest include need for a urinary catheter and development of urinary tract infections.

Full Information

First Posted
September 12, 2022
Last Updated
August 22, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05545280
Brief Title
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine or Sugammadex
Official Title
Postoperative Urinary Retention in Hip and Knee Surgery After Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 hip and knee orthopedic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neostigmine
Arm Type
Active Comparator
Arm Description
Reversal of Neuromuscular Block by Neostigmine.
Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
Reversal of Neuromuscular Block by Sugammadex.
Intervention Type
Drug
Intervention Name(s)
Neostigmine with glycopyrrolate
Intervention Description
Administration by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
Administration by intravenous infusion
Primary Outcome Measure Information:
Title
Urinary retention
Description
The primary outcome of urinary retention is assessed by post-void bladder volume.
Time Frame
1 hour after surgery
Secondary Outcome Measure Information:
Title
Complications related to urinary retention
Description
Complications of interest include need for a urinary catheter and development of urinary tract infections.
Time Frame
end surgery to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed Consent as documented by signature Adults having orthopedic surgery on the lower extremity 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 Exclusion Criteria: Contraindications to the class of drugs under study Preoperative urinary catheter Planned intraoperative insertion of a urinary catheter 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Rodriguez, MD
Phone
216-444-9950
Email
rodrigf3@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Ruetzler, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Rodriguez, MD
Phone
216-444-9950
Email
rodrigf3@ccf.org
First Name & Middle Initial & Last Name & Degree
Xuan PU, MA/MS

12. IPD Sharing Statement

Learn more about this trial

Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine or Sugammadex

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