Residual Neuromuscular BlockadePhase 4NCT03574337
Residual Neuromuscular Blockade in Cardiac Surgery Patients
A Phase 4 study testing Sugammadex and neostigmine/glycopyrolate in people with Residual Neuromuscular Blockade, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Residual Neuromuscular Blockade
- What is being tested?
- Sugammadex and neostigmine/glycopyrolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All outpatients >18 years of age scheduled for elective coronary artery bypass graft surgery (CABG), aortic valve replacement (AVR), or combination CABG/AVR
Who cannot join
- Chronic kidney disease stage IV or V
- Liver disease, defined as AST, ALT or ALP > 1.5x upper limit of normal Inpatient status
- Allergy to rocuronium
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients.
Read the detailed description
Neuromuscular blocking agents are used as part of most general anesthetics to help facilitate tracheal intubation and optimal surgical conditions (Barish et al). These medications cause universal paralysis of patients while unconscious. After most surgeries where extubation is planned, the standard of care is to "reverse" any residual neuromuscular blockade with either anticholinesterase treatment (specifically neostigmine) or sugammadex. Despite adequate reversal, residual neuromuscular blockade is a common problem seen in the post-anesthetic care unit (PACU). It leads to issues of airway obstruction, hypoxemia, respiratory complications including atelectasis and pneumonia and muscle weakness (Brull et al). The investigators posit that these complications are likely amplified in patients who require post-operative intensive care unit admission. In particular, the investigators hypothesize that cardiac surgery patients are at risk. Elective cardiac surgery patients are routinely admitted to the CVICU still intubated and ventilator-dependent immediately following surgery. The goal of uncomplicated cardiac surgery patients (fast track cardiac surgery patients) is to extubate them within 6 hours of ICU arrival. However, standard of care throughout the US does not include reversal of their neuromuscular blockade. By the time these patients meet extubation criteria, most providers believe that the neuromuscular blockade should have worn off and therefore do not administer reversal (Murphy et al). The investigators hypothesize that residual neuromuscular blockade delays time to extubation and increases respiratory complications in fast track cardiac surgery patients. By administering reversal of neuromuscular blockade in patients with a Train Of Four ratio of <0.9 we anticipate that there will be an increase from 60 to 85% of patients being successfully extubated within 6 hours of arrival to the ICU and a decrease in composite respiratory complications.
- Conditions
- Residual Neuromuscular Blockade
- Being tested
- Sugammadex, neostigmine/glycopyrolate
- Keywords
- Residual neuromuscular blockade, Reversal, Cardiac surgery
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
No additional information
neostigmine/glycopyrolateDrug
No additional information
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | Patient's will receive sugammadex at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight and TOF ratio by the pharmacy. It will be a one time dose at the end of the case Receives: Drug: Sugammadex |
| Neostigmine/glycopyrrolate | Active comparator | Patient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight (50mcg/kg of neostigmine with an equivalent volume to volume ratio of glycopyrrolate). It will be a one time dose at the end of the case Receives: Drug: neostigmine/glycopyrolate |
| No reversal administered | No intervention | No reversal administered at the end of the case |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from arrival in CVICU until extubation
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Tidal volumes prior to extubation
Measured: Prior to extubation, the tidal volumes the patient is generating will be documented
Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula
Assess how many liters of oxygen the patient requires to maintain pulse oximetry >92%
Measured: through study completion, an average of 1 year
Lowest documented pulse oximetry
Measured: through study completion, an average of 1 year
Number of participants requiring re-intubation
If the patient is extubated in the intensive care unit but then develops respiratory failure and requires mechanical ventilation again
Measured: through study completion, an average of 1 year
Bronchoscopy
Change in baseline oxygen requirements from prior to the surgery
Measured: through study completion, an average of 1 year
Pneumonia
Change in baseline oxygen requirements from prior to the surgery
Measured: through study completion, an average of 1 year
Intensive care unit length of stay
Measured: through study completion, an average of 1 year
Mortality
Measured: 28 days following the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Aug 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Why it stopped: Inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Jarzebowski, Henry Ford Health System
- Investigators
- Mary Jarzebowski, MD, Principal investigator, Henry Ford Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574337
- Sponsor's protocol ID
- Henryford
- Status last verified
- Feb 2022
- First submitted
- 28 May 2018
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.
PubMed 23076899Richey M, Mann A, He J, Daon E, Wirtz K, Dalton A, Flynn BC. Implementation of an Early Extubation Protocol in Cardiac Surgical Patients Decreased Ventilator Time But Not Intensive Care Unit or Hospital Length of Stay. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):739-744. doi: 10.1053/j.jvca.2017.11.007. Epub 2017 Nov 8.
PubMed 29229252
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Neuromuscular Blockade in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT03574337
- Acronym / sponsor ID
- Henryford
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- Residual neuromuscular blockade, Reversal, Cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 2 Jul 2018 (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 this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients.
Detailed description
Neuromuscular blocking agents are used as part of most general anesthetics to help facilitate tracheal intubation and optimal surgical conditions (Barish et al). These medications cause universal paralysis of patients while unconscious. After most surgeries where extubation is planned, the standard of care is to "reverse" any residual neuromuscular blockade with either anticholinesterase treatment (specifically neostigmine) or sugammadex. Despite adequate reversal, residual neuromuscular blockade is a common problem seen in the post-anesthetic care unit (PACU). It leads to issues of airway obstruction, hypoxemia, respiratory complications including atelectasis and pneumonia and muscle weakness (Brull et al). The investigators posit that these complications are likely amplified in patients who require post-operative intensive care unit admission. In particular, the investigators hypothesize that cardiac surgery patients are at risk. Elective cardiac surgery patients are routinely admitted to the CVICU still intubated and ventilator-dependent immediately following surgery. The goal of uncomplicated cardiac surgery patients (fast track cardiac surgery patients) is to extubate them within 6 hours of ICU arrival. However, standard of care throughout the US does not include reversal of their neuromuscular blockade. By the time these patients meet extubation criteria, most providers believe that the neuromuscular blockade should have worn off and therefore do not administer reversal (Murphy et al). The investigators hypothesize that residual neuromuscular blockade delays time to extubation and increases respiratory complications in fast track cardiac surgery patients. By administering reversal of neuromuscular blockade in patients with a Train Of Four ratio of <0.9 we anticipate that there will be an increase from 60 to 85% of patients being successfully extubated within 6 hours of arrival to the ICU and a decrease in composite respiratory complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: SugammadexPatient's will receive sugammadex at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight and TOF ratio by the pharmacy. It will be a one time dose at the end of the case |
| Neostigmine/glycopyrrolate | Active comparator | Drug: neostigmine/glycopyrolatePatient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight (50mcg/kg of neostigmine with an equivalent volume to volume ratio of glycopyrrolate). It will be a one time dose at the end of the case |
| No reversal administered | No intervention | –No reversal administered at the end of the case |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All outpatients >18 years of age scheduled for elective coronary artery bypass graft surgery (CABG), aortic valve replacement (AVR), or combination CABG/AVR
Key exclusion criteria (3 listed)
- Chronic kidney disease stage IV or V
- Liver disease, defined as AST, ALT or ALP > 1.5x upper limit of normal Inpatient status
- Allergy to rocuronium
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 |
|---|---|---|
| SugammadexNo additional information | Drug | Sugammadex |
| neostigmine/glycopyrolateNo additional information | Drug | Neostigmine/glycopyrrolate |
Primary outcome
Time from arrival in CVICU until extubation
Time frame: through study completion, an average of 1 year
8 secondary outcomes
Tidal volumes prior to extubation
Time frame: Prior to extubation, the tidal volumes the patient is generating will be documented
Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula
Time frame: through study completion, an average of 1 year
Lowest documented pulse oximetry
Time frame: through study completion, an average of 1 year
Number of participants requiring re-intubation
Time frame: through study completion, an average of 1 year
Bronchoscopy
Time frame: through study completion, an average of 1 year
Pneumonia
Time frame: through study completion, an average of 1 year
Intensive care unit length of stay
Time frame: through study completion, an average of 1 year
Mortality
Time frame: 28 days following the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 23076899Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.
- Results publication: PubMed 29229252Richey M, Mann A, He J, Daon E, Wirtz K, Dalton A, Flynn BC. Implementation of an Early Extubation Protocol in Cardiac Surgical Patients Decreased Ventilator Time But Not Intensive Care Unit or Hospital Length of Stay. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):739-744. doi: 10.1053/j.jvca.2017.11.007. Epub 2017 Nov 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mary Jarzebowski, MD principal investigator
Henry Ford Health Systems
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 Sugammadex and neostigmine/glycopyrolate in people with Residual Neuromuscular Blockade, run by Henry Ford Health System 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 16 Feb 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from arrival in CVICU until extubation (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574337, which also lists 2 linked publications.
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 16 Feb 2022.