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

NCT ID: NCT07203287

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-26

Study Completion Date

2027-08-26

Brief Summary

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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."

Detailed Description

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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

Conditions

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Post Operative Pulmonary Complications Neuromuscular Blockade General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rocuronium and Sugammadex (RS) Group

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

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

Sugammadex

Intervention Type DRUG

Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

Cisatracurium and Neostigmine (CN) Group

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

Group Type ACTIVE_COMPARATOR

Cisatracurium

Intervention Type DRUG

Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine

Neostigmine

Intervention Type DRUG

Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine

Interventions

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Rocuronium

Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

Intervention Type DRUG

Cisatracurium

Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine

Intervention Type DRUG

Sugammadex

Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

Intervention Type DRUG

Neostigmine

Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Arango, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Arango, MD

Role: CONTACT

409-996-9197

Facility Contacts

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Daniel Arango, MD

Role: primary

409-996-9197

Other Identifiers

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24-0406

Identifier Type: -

Identifier Source: org_study_id

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