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Re-do Hip and Knee Surgery After Reversal of Neuromuscular Block by Neostigmine or Sugammadex

Sponsor
The Cleveland Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05545280
Collaborator
(none)
286
Enrollment
1
Location
2
Arms
29
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

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 re-do hip and knee orthopedic surgery.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
286 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Postoperative Urinary Retention in Re-do Hip and Knee Surgery After Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Neuromuscular Block

Re-do Hip and Knee Surgery After Reversal of Neuromuscular Block by Neostigmine

Drug: Neostigmine
Neuromuscular Block by Neostigmine
Active Comparator: Reversal of Neuromuscular

Re-do Hip and Knee Surgery After Reversal of Neuromuscular Block by Sugammadex.

Drug: Neostigmine
Neuromuscular Block by Neostigmine

Drug: Sugammadex
Neuromuscular Block by Sugammadex

Outcome Measures

Primary Outcome Measures

  1. Post-Void Bladder Volume [1 hour after surgery]

    The primary outcome will be urinary retention .

Secondary Outcome Measures

  1. Complications related to urinary retention [1 hour after surgery]

    Investigate complications related to postoperative urinary retention after re-do hip and knee surgeries in patients in who neuromuscular blocks are reversed by sugammadex or neostigmine. Complications of interest include need for a urinary catheter and development of urinary tract infections.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Informed Consent as documented by signature;

  • Adults having secondary orthopedic surgery on the lower extremity;

  • 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 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;

  • Conditions or comorbidities that provoke urinary retention;

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Study Chair: Daniel I Sessler, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT05545280
Other Study ID Numbers:
  • 22-745
First Posted:
Sep 19, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neostigmine

Study Results

No Results Posted as of Sep 19, 2022