Neuromuscular BlockadePhase 4NCT04606901
Comparison of Time to Extubation Using Sugammadex or Neostigmine
A Phase 4 study testing neostigmine/glycopyrrolate and sugammadex in people with Neuromuscular Blockade and Chronic Obstructive Pulmonary Disease, run by Temple University at 1 site in United States.
Trial summary
A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Neuromuscular Blockade, Chronic Obstructive Pulmonary Disease
- What is being tested?
- neostigmine/glycopyrrolate and sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 30 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has diagnosis of COPD or ILD
- ASA 3 or 4
- procedure requires general anesthesia in the outpatient bronchoscopy suite
- glomerular filtration rate > 30 ml/min
Who cannot join
- pregnant women
- prisoners
- those unable to consent for themselves
- procedures not requiring general anesthesia
- ASA 1 or 2
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Comparison of Time to Full Recovery From Muscle Paralysis (TOF>0.9) and Extubation Using Sugammadex Versus Neostigmine/Glycopyrrolate in Patients With Pulmonary Disease in the Outpatient Bronchoscopy Suite
A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite.
Read the detailed description
This research study will have the design of a blinded randomized clinical trial. The pharmacist will be blinded to the study medication given. The anesthesia provider cannot be blinded because he/she will need to determine the proper dose and timing of the neuromuscular blocker reversal medication (the study medications) given at the end of the procedure. The study will recruit 80 patients coming to Temple University Hospital for an outpatient bronchoscopy biopsy procedure that requires general anesthesia with neuromuscular blockade. Rocuronium will be the neuromuscular blockade medication given in this study. Inclusion criteria for these patients will include those age >18 who have a diagnosis of chronic obstructive pulmonary disease (COPD) and/or idiopathic lung disease (ILD) and who require medical treatment for the same; these patients will have American society of anesthesiology physical status (ASA PS) 3-4 based on their pulmonary disease alone.The patients will then be randomly assigned to one of two study arms (40 per arm). Patients in one arm of the study will receive Sugammadex and patients in the other arm will receive neostigmine/glycopyrrolate for reversal of neuromuscular blockade. Due to the nature of bronchoscopy for biopsy, the depth of anesthesia at the end of the case will be difficult to predict; the length of the cases may vary some (although most will be approximately one hour), and patients' metabolism of neuromuscular blocking agents is very much dependent on their personal medication regimens and liver function. Each patient's depth of neuromuscular blockade will be followed using the TwitchView monitor, a commercially available, an electromyography (EMG) based monitor. The TwitchView measures muscle response to delivered electrical stimuli (2Hz) which are sent in sets of 4X0.5 seconds apart (most commonly). The muscles controlled by the ulnar nerve will be followed during this study. Return of muscle strength after reversal agents are given is considered complete when the ratio of the strength of the response to the fourth electrical stimulus to the first stimulus is 0.9. Multiple time points will be recorded, including train of four measurement (TOF) every 5 minutes during the procedure, time and TOF at the end of the procedure, time of reversal medication dosing, time of TOF>0.9 and time of extubation. Reversal medication will be given as soon as each patient's procedure is complete and the patient meets appropriate criteria for reversal for each respective medication. Comparison of the data from the two arms of the study will then be made.
- Being tested
- neostigmine/glycopyrrolate, sugammadex
- Keywords
- Nondepolarizing neuromuscular blockade, sugammadex, bronchoscopy, outpatient, lung disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmine/glycopyrrolateDrug
Also called prostigmin/robinul
neuromuscular blockade reversal agents
sugammadexDrug
Also called Bridion
neuromuscular blockade reversal agent
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. Receives: Drug: sugammadex |
| Neostigmine/Glycopyrrolate | Active comparator | Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade Receives: Drug: neostigmine/glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Minutes to Return of Baseline Muscle Tone
number of minutes from reversal dose to Train of Four (TOF) >0.9 indicating full reversal of neuromuscular blockade agent
Measured: 1-20 minutes
Secondary outcomes (1)
Number of Minutes to Extubation
number of minutes from Train of Four (TOF) >0.9 to extubation of the patient
Measured: 1-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start8 Apr 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular BlockadeStudies 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
- Model description
- Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Ellen Hauck, DO PhD, Principal investigator, Lewis Katz School of Medicine at Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606901
- Sponsor's protocol ID
- 26881
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2020
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only deidentified data from the study will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Time to Full Recovery From Muscle Paralysis (TOF>0.9) and Extubation Using Sugammadex Versus Neostigmine/Glycopyrrolate in Patients With Pulmonary Disease in the Outpatient Bronchoscopy Suite
- ClinicalTrials.gov ID
- NCT04606901
- Acronym / sponsor ID
- 26881
- Keywords
- Nondepolarizing neuromuscular blockade, sugammadex, bronchoscopy, outpatient, lung disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite.
Detailed description
This research study will have the design of a blinded randomized clinical trial. The pharmacist will be blinded to the study medication given. The anesthesia provider cannot be blinded because he/she will need to determine the proper dose and timing of the neuromuscular blocker reversal medication (the study medications) given at the end of the procedure. The study will recruit 80 patients coming to Temple University Hospital for an outpatient bronchoscopy biopsy procedure that requires general anesthesia with neuromuscular blockade. Rocuronium will be the neuromuscular blockade medication given in this study. Inclusion criteria for these patients will include those age >18 who have a diagnosis of chronic obstructive pulmonary disease (COPD) and/or idiopathic lung disease (ILD) and who require medical treatment for the same; these patients will have American society of anesthesiology physical status (ASA PS) 3-4 based on their pulmonary disease alone.The patients will then be randomly assigned to one of two study arms (40 per arm). Patients in one arm of the study will receive Sugammadex and patients in the other arm will receive neostigmine/glycopyrrolate for reversal of neuromuscular blockade. Due to the nature of bronchoscopy for biopsy, the depth of anesthesia at the end of the case will be difficult to predict; the length of the cases may vary some (although most will be approximately one hour), and patients' metabolism of neuromuscular blocking agents is very much dependent on their personal medication regimens and liver function. Each patient's depth of neuromuscular blockade will be followed using the TwitchView monitor, a commercially available, an electromyography (EMG) based monitor. The TwitchView measures muscle response to delivered electrical stimuli (2Hz) which are sent in sets of 4X0.5 seconds apart (most commonly). The muscles controlled by the ulnar nerve will be followed during this study. Return of muscle strength after reversal agents are given is considered complete when the ratio of the strength of the response to the fourth electrical stimulus to the first stimulus is 0.9. Multiple time points will be recorded, including train of four measurement (TOF) every 5 minutes during the procedure, time and TOF at the end of the procedure, time of reversal medication dosing, time of TOF>0.9 and time of extubation. Reversal medication will be given as soon as each patient's procedure is complete and the patient meets appropriate criteria for reversal for each respective medication. Comparison of the data from the two arms of the study will then be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: sugammadexPatients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. |
| Neostigmine/Glycopyrrolate | Active comparator | Drug: neostigmine/glycopyrrolatePatients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- has diagnosis of COPD or ILD
- ASA 3 or 4
- procedure requires general anesthesia in the outpatient bronchoscopy suite
- glomerular filtration rate > 30 ml/min
Key exclusion criteria (5 listed)
- pregnant women
- prisoners
- those unable to consent for themselves
- procedures not requiring general anesthesia
- ASA 1 or 2
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 |
|---|---|---|
| neostigmine/glycopyrrolateAlso: prostigmin/robinulneuromuscular blockade reversal agents | Drug | Neostigmine/Glycopyrrolate |
| sugammadexAlso: Bridionneuromuscular blockade reversal agent | Drug | Sugammadex |
Primary outcome
Number of Minutes to Return of Baseline Muscle Tone
Time frame: 1-20 minutes
number of minutes from reversal dose to Train of Four (TOF) >0.9 indicating full reversal of neuromuscular blockade agent
1 secondary outcome
Number of Minutes to Extubation
Time frame: 1-30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only deidentified data from the study will be made available to other researchers
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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.
Ellen Hauck, DO PhD principal investigator
Lewis Katz School of Medicine at Temple University
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 neostigmine/glycopyrrolate and sugammadex in people with Neuromuscular Blockade and Chronic Obstructive Pulmonary Disease, run by Temple University 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 5 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: finished, as of the sponsor's last update on 13 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Minutes to Return of Baseline Muscle Tone (time frame: 1-20 minutes). 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 13 Mar 2024.