Safer muscle relaxant and reversal choice during anesthesia for people with chronic kidney disease
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
This trial will try to see if using cisatracurium with neostigmine leads to fewer breathing problems after surgery than using rocuronium with sugammadex in adults who have chronic kidney disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT07203287 on ClinicalTrials.gov |
What this trial studies
Adults with chronic kidney disease undergoing elective surgery with general anesthesia are randomized to receive either rocuronium with sugammadex or cisatracurium with neostigmine as the neuromuscular blocker and reversal regimen. Both approaches are current standard-of-care options and reversal will be performed and documented per protocol. Patients are followed for up to seven days after surgery for postoperative pulmonary complications such as atelectasis, hypoxia, respiratory failure, pneumonia, and pneumothorax. The study excludes patients with end-stage renal disease, those on dialysis, transplant recipients, pregnant patients, and emergency procedures.
Who should consider this trial
Good fit: Adults aged 18–80 with chronic kidney disease (reduced GFR) scheduled for elective surgery requiring general anesthesia and endotracheal intubation, who are not on dialysis and can give informed consent, are ideal candidates.
Not a fit: Patients with end-stage renal disease, those requiring dialysis, renal transplant recipients, pregnant women, incarcerated individuals, emergency surgeries, or those needing postoperative intubation are excluded and therefore will not benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify a safer anesthesia drug combination that reduces postoperative breathing complications in people with chronic kidney disease.
How similar studies have performed: Both drug combinations are widely used in practice, but direct randomized comparisons focused on postoperative pulmonary outcomes specifically in chronic kidney disease patients are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Michael Kinsky, MD — University of Texas
- Study coordinator: Michael Kinsky, MD
- Email: mkinsky@utmb.edu
- Phone: 409-772-1011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.