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Purpose

The purpose of the study is to determine which combination of neuromuscular blocking agent and reversal agent is safer to use during anesthesia for patients with chronic kidney disease. The main question it aims to answer is "The use of Cisatracurium with neostigmine leads to less post-operative pulmonary complications than Rocuronium with sugammadex."

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • The subject is able and willing to provide and sign informed consent - The subject must be between 18 and 80 years of age - The subject should have chronic kidney disease as defined by glomerular filtration rate - The surgery must require general anesthesia with endotracheal intubation and neuromuscular blockade

Exclusion Criteria

  • Any patient under the age of 18 - Any patient over the age of 80 - Any patient with end stage renal disease - Any patient requiring dialysis - Patients presenting for Renal Transplantation - Pregnant Female - Any patient in the correctional system - Urgent or Emergent procedure - The surgery requires intubation post-operatively - Documented allergy to Rocuronium, Sugammadex, Cisatracurium or Neostigmine

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Rocuronium and Sugammadex (RS) Group 		The participants will be given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal.
  • Drug: Rocuronium
    Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex
    Other names:
    • Sugammadex
Active Comparator
Cisatracurium and Neostigmine (CN) Group 		The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal.
  • Drug: Cisatracurium
    Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine
    Other names:
    • Neostigmine

Recruiting Locations

University of Texas Medical Branch
Galveston 4692883, Texas 4736286 77554
Contact:
Daniel Arango, MD
409-996-9197
daarango@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Daniel Arango, MD
409-996-9197
daarango@utmb.edu

Detailed Description

Participants will be randomized into one of the two groups (Group 1-Given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal or Group 2-Given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal). Both of which are current standard of care practices. Appropriate reversal will be performed and documented, and the patient will go to the recovery room or intensive care unit as planned preoperatively. The patients will be assessed postoperatively for up to 7 days for any signs of respiratory complications, including but not limited to: 1. Atelectesis 2. Hypoxia 3. Respiratory distress/failure 4. Pneumonia 5. Pneumothrax

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.