Neuromuscular BlockadePhase 4NCT03322657
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
A Phase 4 study testing Neostigmine, Glycopyrrolate and Sugammadex in people with Neuromuscular Blockade and Anesthesia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Anesthesia
- What is being tested?
- Neostigmine, Glycopyrrolate and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 1 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
- General anesthesia.
Who cannot join
- Suspected difficult intubation;
- Neuromuscular disorder;
- Renal impairment creatinine ≥ 2 mg /dl;
- Hepatic dysfunction;
- History of malignant hyperthermia;
- Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
Show all 9Show fewer
- Perioperative respiratory infections and/or pneumonia;
- Intubated or unresponsive;
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures
The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
Read the detailed description
Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).
Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.
Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.
Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.
- Conditions
- Neuromuscular Blockade, Anesthesia
- Being tested
- Neostigmine, Glycopyrrolate, Sugammadex
- Keywords
- Sugammadex, Neostigmine, Reversal of neuromuscular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Neostigmine injection
GlycopyrrolateDrug
Glycopyrrolate injection
SugammadexDrug
Sugammadex injection
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine with glycopyrrolate | Active comparator | Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery Receives: Drug: Neostigmine; Drug: Glycopyrrolate |
| Sugammadex | Experimental | Sugammadex 4 mg/kg at the end surgery Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.
Measured: within 90 minutes after endotracheal extubation
TOF Ratio at 90 Min
TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board.
Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis.
Measured: at 90 minutes after the administration of the reversal agent
Secondary outcomes (3)
The Time for Extubation After Administration of Reversal Agents
Time from administration of reversal agent to tracheal extubation
Measured: Up to 4 hours after administration of reversal agents
Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
Measured: from baseline to 90 minutes after the administration of the reversal agent
Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
Measured: from baseline to 90 minutes after the administration of reversal agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start14 Nov 2017
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Farag, MD, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322657
- Sponsor's protocol ID
- 17-764
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2017
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Farag E, Rivas E, Bravo M, Hussain S, Argalious M, Khanna S, Seif J, Pu X, Mao G, Bain M, Elgabaly M, Esa WAS, Sessler DI. Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-Based Neurointerventional Procedures: A Randomized Trial. Anesth Analg. 2021 Jun 1;132(6):1666-1676. doi: 10.1213/ANE.0000000000005533.
PubMed 34032663
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures
- ClinicalTrials.gov ID
- NCT03322657
- Acronym / sponsor ID
- 17-764
- Conditions
- Neuromuscular Blockade, Anesthesia
- Keywords
- Sugammadex, Neostigmine, Reversal of neuromuscular block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
Detailed description
Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).
Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.
Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.
Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine with glycopyrrolate | Active comparator | Drug: Neostigmine, Drug: GlycopyrrolateNeostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery |
| Sugammadex | Experimental | Drug: SugammadexSugammadex 4 mg/kg at the end surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
- General anesthesia.
Key exclusion criteria (9 listed)
- Suspected difficult intubation;
- Neuromuscular disorder;
- Renal impairment creatinine ≥ 2 mg /dl;
- Hepatic dysfunction;
- History of malignant hyperthermia;
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 |
|---|---|---|
| NeostigmineNeostigmine injection | Drug | Neostigmine with glycopyrrolate |
| GlycopyrrolateGlycopyrrolate injection | Drug | Neostigmine with glycopyrrolate |
| SugammadexSugammadex injection | Drug | Sugammadex |
Primary outcome
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
Time frame: within 90 minutes after endotracheal extubation
The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.
TOF Ratio at 90 Min
Time frame: at 90 minutes after the administration of the reversal agent
TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board. Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis.
3 secondary outcomes
The Time for Extubation After Administration of Reversal Agents
Time frame: Up to 4 hours after administration of reversal agents
Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s
Time frame: from baseline to 90 minutes after the administration of the reversal agent
Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s
Time frame: from baseline to 90 minutes after the administration of reversal agent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34032663Farag E, Rivas E, Bravo M, Hussain S, Argalious M, Khanna S, Seif J, Pu X, Mao G, Bain M, Elgabaly M, Esa WAS, Sessler DI. Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-Based Neurointerventional Procedures: A Randomized Trial. Anesth Analg. 2021 Jun 1;132(6):1666-1676. doi: 10.1213/ANE.0000000000005533.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia, run by The Cleveland Clinic 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 9 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 16 Nov 2021. 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 8 Apr 2021). 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?
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent (time frame: within 90 minutes after endotracheal extubation). The study lists 2 primary outcomes in all. 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 NCT03322657, which also lists 1 linked publication.
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 Nov 2021.