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

NCT07203287 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 24-0406
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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."

Conditions

Post Operative Pulmonary Complications; Neuromuscular Blockade; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Hospital Length of Stay

  7 days

• Post Anesthesia Care Unit (PACU) length of stay

  7 days

• Number of patients with cardiac instability

  7 days

Study Arms (2)

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.

Drug: Rocuronium; Drug: Sugammadex

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.

Drug: Cisatracurium; Drug: Neostigmine

Interventions

Rocuronium DRUG

Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

Rocuronium and Sugammadex (RS) Group

Cisatracurium DRUG

Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine

Cisatracurium and Neostigmine (CN) Group

Sugammadex DRUG

Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

Rocuronium and Sugammadex (RS) Group

Neostigmine DRUG

Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine

Cisatracurium and Neostigmine (CN) Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77554, United States

RECRUITING

MeSH Terms

Interventions

Rocuronium; cisatracurium; Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Michael Kinsky, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Kinsky, MD

CONTACT

409-772-1011; mkinsky@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 26, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)