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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."
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium and Sugammadex (RS) Group | Active Comparator | The participants will be given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal. |
|
| Cisatracurium and Neostigmine (CN) Group | Active Comparator | The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pulmonary Complications (PPCs) | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | The total number of days the participant spent in the hospital. | 7 days |
| Post Anesthesia Care Unit (PACU) length of stay | The total number of days the patient spent in the PACU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Kinsky, MD | Contact | 409-772-1011 | mkinsky@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Kinsky, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77554 | United States |
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| Cisatracurium | Drug | Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine |
|
| Sugammadex | Drug | Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex |
|
| Neostigmine | Drug | Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine |
|
| 7 days |
| Number of patients with cardiac instability | 7 days |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| C101584 | cisatracurium |
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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