Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Post Operative Pulmonary Complications; General Anesthesia; Neuromuscular Blockade

Treatments: Drug: Neostigmine; Drug: Rocuronium; Drug: Sugammadex; Drug: Cisatracurium

Study type: Interventional

Funder types: Other

Identifiers

NCT07203287

24-0406

Details and patient eligibility

About

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."

Full 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

Enrollment: 490 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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490 participants in 2 patient groups

Rocuronium and Sugammadex (RS) Group

Active Comparator group

Description:

The participants will be given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal.

Treatment:

Drug: Sugammadex

Drug: Rocuronium

Cisatracurium and Neostigmine (CN) Group

Active Comparator group

Description:

The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal.

Treatment:

Drug: Cisatracurium

Drug: Neostigmine