General Anesthesia, Neuromuscular Blockade, Post Operative Pulmonary Complications
Conditions
Brief summary
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
DRUGRocuronium
Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex
DRUGCisatracurium
Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine
DRUGSugammadex
Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex
DRUGNeostigmine
Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pulmonary Complications (PPCs) | 7 days | PPCs will be scored using a grading scale where 0 = no complication, 1 = mild, 2 = moderate, and 3 = severe complication, with 0 as the minimum score and 3 as the maximum score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 7 days | The total number of days the participant spent in the hospital. |
| Post Anesthesia Care Unit (PACU) length of stay | 7 days | The total number of days the patient spent in the PACU. |
| Number of patients with cardiac instability | 7 days | — |
Countries
United States
Contacts
CONTACTMichael Kinsky, MD
PRINCIPAL_INVESTIGATORMichael Kinsky, MD
University of Texas
Outcome results
None listed