Health TrialsbyHealthPanel

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

ConditionsPost Operative Pulmonary ComplicationsNeuromuscular BlockadeGeneral Anesthesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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."

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rocuronium

    Drug

    Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex

  • 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

Treatment groups

490 Participants
are divided into 2 treatment groups
Group A: Rocuronium and Sugammadex (RS) GroupActive comparator 2 interventions
Group B: Cisatracurium and Neostigmine (CN) GroupActive comparator 2 interventions

Trial outcomes

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.

Time frame
7 days

Secondary outcomes

1

Hospital Length of Stay

The total number of days the participant spent in the hospital.

Time frame
7 days
2

Post Anesthesia Care Unit (PACU) length of stay

The total number of days the patient spent in the PACU.

Time frame
7 days
3

Number of patients with cardiac instability

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Medical Branch, Galveston

Lead sponsor

Source ClinicalTrials.gov
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