Rocuronium vs Cisatracurium for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two medicines, Rocuronium and Cisatracurium, to determine which is safer for people with chronic kidney disease during surgery. These medicines relax muscles during anesthesia. The trial aims to see if using Cisatracurium with Neostigmine results in fewer post-surgery breathing problems than using Rocuronium with Sugammadex. Individuals with chronic kidney disease who require surgery with general anesthesia involving muscle relaxants might be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that rocuronium with sugammadex can safely reverse muscle relaxation in patients with kidney issues. However, some studies suggest caution with sugammadex in individuals with severe kidney disease, as their bodies might not clear it effectively.
Cisatracurium, by contrast, is considered safer for patients with kidney problems because it breaks down in the body independently of the kidneys. Some studies also found that using rocuronium with sugammadex might lead to more heart and lung problems compared to cisatracurium.
In summary, while both treatments have been used safely, cisatracurium might be the better option for those with chronic kidney problems.12345Why are researchers enthusiastic about this study treatment?
Most treatments for neuromuscular blockade in patients with chronic kidney disease use cisatracurium, which is paired with neostigmine for reversal. However, researchers are excited about using rocuronium with sugammadex because it offers a different approach. Sugammadex works rapidly to reverse rocuronium's effects by encapsulating the drug, which could lead to quicker recovery times and fewer side effects compared to neostigmine. This approach could potentially enhance safety and comfort for patients with kidney issues, who often have to be cautious about drug clearance and side effects.
What evidence suggests that this trial's treatments could be effective for chronic kidney disease?
This trial will compare the effectiveness of two treatment regimens for patients with chronic kidney disease. Participants in one arm will receive cisatracurium with neostigmine, a combination that research has shown effectively reverses muscle relaxation after surgery without relying on kidney clearance, thus reducing the risk of complications. Participants in the other arm will receive rocuronium with sugammadex. Studies indicate that sugammadex can safely reverse muscle relaxation caused by rocuronium in patients with severe kidney disease, although the effects may last longer, potentially slowing recovery. Both options offer advantages, and the choice usually depends on the patient's specific needs and health conditions.678910
Who Is on the Research Team?
Daniel Arango, MD
Principal Investigator
University of Texas
Are You a Good Fit for This Trial?
This trial is for patients with chronic kidney disease who need general anesthesia and neuromuscular blockade during surgery. Specific eligibility criteria are not provided, but typically participants would be adults with varying stages of kidney disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either rocuronium and sugammadex or cisatracurium and neostigmine during anesthesia
Postoperative Monitoring
Participants are assessed for respiratory complications for up to 7 days postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisatracurium
- Rocuronium
Trial Overview
The study compares the safety of two muscle relaxants—Rocuronium and Cisatracurium—used during surgery in patients with chronic kidney disease. It will assess if using Cisatracurium with neostigmine results in fewer post-operative lung problems than Rocuronium with sugammadex.
How Is the Trial Designed?
2
Treatment groups
Active Control
The participants will be given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal.
The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Citations
Sugammadex administration in patients with end-stage ...
Studies have shown that sugammadex can effectively and safely reverse rocuronium-induced neuromuscular blockade (NMB) in patients with ESRD.
Sugammadex administration in patients with end-stage ...
They concluded that sugammadex is safe and effective. Paredes et al. [16] reported a cohort study of. 219 patients with stage 5 chronic kidney disease who re-.
Reduced clearance of rocuronium and sugammadex in ...
The median amount of sugammadex and rocuronium excreted in the urine over 72 h in renal patients was 29% and 4%, respectively, and 73% and 42% over 24 h in ...
Critical Care Dialysability of sugammadex and its complex ...
The action of both sugammadex and rocuronium is prolonged in renal failure patients. · Study of the effect of haemodialysis on the sugammadex–rocuronium complex.
Efficacy and Safety of Sugammadex for the Reversal of ... - PMC
Sugammadex may effectively and safely reverse rocuronium-induced NMB in patients with ESRD, although the recovery to a TOF ratio of 0.9 may be prolonged.
Risk of Acute Complications with Rocuronium versus ...
Conclusions: From 2003 to 2023, patients who were administered rocuronium plus sugammadex were at a significantly higher risk for acute ...
7.
journals.lww.com
journals.lww.com/anesthesia-analgesia/fulltext/9900/choice_of_neuromuscular_blocker_and_reversal_in.1539.aspxChoice of Neuromuscular Blocker and Reversal in Setting ...
Risk of acute complications with rocuronium versus cisatracurium in patients with chronic kidney disease: a propensity-matched study. Anesth ...
Use of Neuromuscular Blocking and Antagonism Agents ...
Cisatracurium has been traditionally been utilized in patients with severe renal impairment due to its clearance by Hoffman elimination.
Risk of Acute Complications With Rocuronium vs ...
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease. ClinicalTrials.gov ID NCT07203287.
10.
researchexperts.utmb.edu
researchexperts.utmb.edu/en/publications/risk-of-acute-complications-with-rocuronium-versus-cisatracurium-Risk of Acute Complications with Rocuronium versus ...
Patients who were administered rocuronium plus sugammadex were at a significantly higher risk for acute cardiovascular and pulmonary complications.
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