Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rocuronium, Cisatracurium, Sugammadex, Neostigmine.
- Who it may be relevant to
- Registry conditions: Post Operative Pulmonary Complications, Neuromuscular Blockade, General Anesthesia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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."
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
Interventions
- Drug Rocuronium
Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex - Drug Cisatracurium
Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine - Drug Sugammadex
Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex - Drug Neostigmine
Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine
Primary outcome measures
- Post Operative Pulmonary Complications (PPCs) [Time frame: 7 days]
Secondary outcome measures (3)
- Hospital Length of Stay [Time frame: 7 days]
- Post Anesthesia Care Unit (PACU) length of stay [Time frame: 7 days]
- Number of patients with cardiac instability [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT07203287 · 24-0406