Post Operative Pulmonary ComplicationsPhase 4NCT07203287
Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
A Phase 4 study testing Rocuronium, Cisatracurium and Sugammadex in people with Post Operative Pulmonary Complications and Neuromuscular Blockade, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pulmonary Complications, Neuromuscular Blockade, General Anesthesia
- What is being tested?
- Rocuronium, Cisatracurium and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 26 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77554
Michael Kinsky, MD, 409-772-1011, mkinsky@utmb.edu
About this study
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."
Read the 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:
- Atelectesis
- Hypoxia
- Respiratory distress/failure
- Pneumonia
- Pneumothrax
- Being tested
- Rocuronium, Cisatracurium, Sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex
CisatracuriumDrug
Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine
SugammadexDrug
Will be assessing neuromuscular blockade with rocuronium and reversal with sugammadex
NeostigmineDrug
Will be assessing neuromuscular blockade with neostigmine and reversal with neostigmine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cisatracurium; Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (3)
Hospital Length of Stay
The total number of days the participant spent in the hospital.
Measured: 7 days
Post Anesthesia Care Unit (PACU) length of stay
The total number of days the patient spent in the PACU.
Measured: 7 days
Number of patients with cardiac instability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start26 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pulmonary ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kinsky, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203287
- Sponsor's protocol ID
- 24-0406
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07203287
- Acronym / sponsor ID
- 24-0406
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Atelectesis
- Hypoxia
- Respiratory distress/failure
- Pneumonia
- Pneumothrax
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium and Sugammadex (RS) Group | Active comparator | Drug: Rocuronium, Drug: SugammadexThe 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 | Active comparator | Drug: Cisatracurium, Drug: NeostigmineThe participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocuroniumWill be assessing neuromuscular blockade with rocuronium and reversal with sugammadex | Drug | Rocuronium and Sugammadex (RS) Group |
| CisatracuriumWill be assessing neuromuscular blockade with neostigmine and reversal with neostigmine | Drug | Cisatracurium and Neostigmine (CN) Group |
| SugammadexWill be assessing neuromuscular blockade with rocuronium and reversal with sugammadex | Drug | Rocuronium and Sugammadex (RS) Group |
| NeostigmineWill be assessing neuromuscular blockade with neostigmine and reversal with neostigmine | Drug | Cisatracurium and Neostigmine (CN) Group |
Primary outcome
Post Operative Pulmonary Complications (PPCs)
Time frame: 7 days
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.
3 secondary outcomes
Hospital Length of Stay
Time frame: 7 days
Post Anesthesia Care Unit (PACU) length of stay
Time frame: 7 days
Number of patients with cardiac instability
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Gynecologic Surgery, High-flow Nasal Cannula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Kinsky, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium, Cisatracurium and Sugammadex in people with Post Operative Pulmonary Complications and Neuromuscular Blockade, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Kinsky, MD (409-772-1011, mkinsky@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Pulmonary Complications (PPCs) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.