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

Not Applicable

Recruiting

• Conditions: Post Operative Pulmonary Complications; Neuromuscular Blockade; General Anesthesia
• Interventions: Drug: Rocuronium; Drug: Cisatracurium

• Registration Number: NCT07203287
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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

Study Timeline

• Study Start: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Primary Completion: 2025-09-26
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Completion: 2027-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium and Sugammadex (RS) Group	Rocuronium	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	Cisatracurium	The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal.

Primary Outcome Measures

Name	Time	Method
Post Operative Pulmonary Complications (PPCs)	7 days	PPCs are a set of pulmonary complications diagnosed based on various clinical measures and described on a grading scale.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States