Diaphragmatic DysfunctionPhase 3SUDIANCT01962298
Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex
A Phase 3 study testing sugammadex 2mg/kg, neostigmine and sugammadex 4mg/kg in people with Diaphragmatic Dysfunction and Muscle Weakness, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Dysfunction, Muscle Weakness, Muscle Fatigue
- What is being tested?
- sugammadex 2mg/kg, neostigmine and sugammadex 4mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 3
- 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
- Each participant must have the mental capacity to decide whether he/she takes part in the trial or not. Each participant must voluntarily give his/her written informed consent. In case a participant is physically unable to give a written informed consent, a legal representative is to perform this.
- Each participant must be at least eighteen years of age. Participants can be of either sex and of any ethnical background.
- Each participant must meet the American Society of Anesthesiologists class II, II or III criteria.
- Each participant must be scheduled for intracranial surgery. During general anesthesia rocuronium must be used as a neuromuscular blocking agent.
- Each participant must be a suitable candidate for the rapid reversal of the neuromuscular blockade.
- Each female participant of sexually active age and of childbearing potential must agree to the use of a medically accepted method of contraception through seven days after the day of surgery. Postmenopausal (defined as at least twelve consecutive months without spontaneous menstrual period) women are not obliged to use contraceptives.
Who cannot join
- The participant is known or suspected to have a neuromuscular disorder.
- The participant is known or suspected to have an allergic reaction to sugammadex, rocuronium, anesthetic or narcotic medications, or any drugs used during general anesthesia.
- The participant is known or suspected to have an anatomical malformation impeding a proper intubation.
- The participant is known or suspected to have a history of malignant hyperthermia.
- The participant is pregnant (or intends to become pregnant within the presurgical period) or lactating.
- The participant is known to have a renal insufficiency (defined as a serum creatinine concentration of two times the upper limit, or a glomerular filtration rate of less than 60 ml/min).
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- The participant is known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher or has any respiratory disease that impairs his respiratory function to a NYHA III level or worse.
- The participant is known to have an infection of the upper or lower airways, as diagnosed by clinical or laboratory findings.
- The participant is known or suspected to have congestive heart failure.
- The participant is obese, as defined by a body mass index of 30 kg/m2 or more.
- The participant is known or suspected to have a major hepatic dysfunction.
- The participant has received or is scheduled to receive toremifene and/or an intravenous administration of fusidic acid within a time span of twenty-four hours before and twenty-four hours after the surgery.
- The participant is known or suspected to have any condition contraindicating the administration of sugammadex, neostigmine, glycopyrrolate or placebo.
- The participant is known or suspected to be directly involved in this study and/or is employed by or is a family member of any person employed by the investigator, at the investigational site, or by the sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sugammadex and the Diaphragm: Recovery of Diaphragmatic Function and Neuromuscular Blockade. A Double-blind Randomized Controlled Trial
The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles.
Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking agents and their reversal agents we might see a different activity of the respiratory muscles.
- Conditions
- Diaphragmatic Dysfunction, Muscle Weakness, Muscle Fatigue
- Being tested
- sugammadex 2mg/kg, neostigmine, sugammadex 4mg/kg, placebo, Single rocuronium dose
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadex 2mg/kgDrug
neostigmineDrug
sugammadex 4mg/kgDrug
placeboDrug
Single rocuronium doseDrug
Repeated rocuronium doseDrug
Continuous rocuronium infusionDrug
| Study group | Role | What they receive |
|---|---|---|
| Single rocuronium dose - placebo | Placebo comparator | The patients will receive a single rocuronium dose, and no reversal agent. Receives: Drug: placebo; Drug: Single rocuronium dose |
| Single rocuronium dose - sugammadex | Active comparator | The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent Receives: Drug: sugammadex 2mg/kg; Drug: Single rocuronium dose |
| Repeated rocuronium dose - neostigmine | Active comparator | The patients will receive multiple rocuronium doses and neostigmine 70 mcg/kg as a reversal agent Receives: Drug: neostigmine; Drug: Repeated rocuronium dose |
| Repeated rocuronium dose - sugammadex | Active comparator | The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent Receives: Drug: sugammadex 2mg/kg; Drug: Repeated rocuronium dose |
| Continuous rocuronium dose | Active comparator | The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent Receives: Drug: sugammadex 4mg/kg; Drug: Continuous rocuronium infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electric Activity of the Diaphragm (Microvolts)
Measured: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing
Secondary outcomes (1)
Electric Activity of the Intercostal Muscles
Measured: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Diaphragmatic DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Schepens, MD, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962298
- Sponsor's protocol ID
- EC 13/5/60
- Other IDs
- 2013-001926-25, B300201316844
- Acronym
- SUDIA
- Status last verified
- Mar 2018
- First submitted
- 9 Oct 2013
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dres M, Schmidt M, Ferre A, Mayaux J, Similowski T, Demoule A. Diaphragm electromyographic activity as a predictor of weaning failure. Intensive Care Med. 2012 Dec;38(12):2017-25. doi: 10.1007/s00134-012-2700-3. Epub 2012 Sep 26.
PubMed 23011532Schepens T, Janssens K, Maes S, Wildemeersch D, Vellinga J, Jorens PG, Saldien V. Respiratory muscle activity after spontaneous, neostigmine- or sugammadex-enhanced recovery of neuromuscular blockade: a double blind prospective randomized controlled trial. BMC Anesthesiol. 2019 Oct 19;19(1):187. doi: 10.1186/s12871-019-0863-y.
PubMed 31629404
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex and the Diaphragm: Recovery of Diaphragmatic Function and Neuromuscular Blockade. A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01962298
- Acronym / sponsor ID
- SUDIA / EC 13/5/60
- Conditions
- Diaphragmatic Dysfunction, Muscle Weakness, Muscle Fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Posted 24 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles.
Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking agents and their reversal agents we might see a different activity of the respiratory muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single rocuronium dose - placebo | Placebo comparator | Drug: placebo, Drug: Single rocuronium doseThe patients will receive a single rocuronium dose, and no reversal agent. |
| Single rocuronium dose - sugammadex | Active comparator | Drug: sugammadex 2mg/kg, Drug: Single rocuronium doseThe patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent |
| Repeated rocuronium dose - neostigmine | Active comparator | Drug: neostigmine, Drug: Repeated rocuronium doseThe patients will receive multiple rocuronium doses and neostigmine 70 mcg/kg as a reversal agent |
| Repeated rocuronium dose - sugammadex | Active comparator | Drug: sugammadex 2mg/kg, Drug: Repeated rocuronium doseThe patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent |
| Continuous rocuronium dose | Active comparator | Drug: sugammadex 4mg/kg, Drug: Continuous rocuronium infusionThe participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Each participant must have the mental capacity to decide whether he/she takes part in the trial or not. Each participant must voluntarily give his/her written informed consent. In case a participant is physically unable to give a written informed consent, a legal representative is to perform this.
- Each participant must be at least eighteen years of age. Participants can be of either sex and of any ethnical background.
- Each participant must meet the American Society of Anesthesiologists class II, II or III criteria.
- Each participant must be scheduled for intracranial surgery. During general anesthesia rocuronium must be used as a neuromuscular blocking agent.
- Each participant must be a suitable candidate for the rapid reversal of the neuromuscular blockade.
Key exclusion criteria (14 listed)
- The participant is known or suspected to have a neuromuscular disorder.
- The participant is known or suspected to have an allergic reaction to sugammadex, rocuronium, anesthetic or narcotic medications, or any drugs used during general anesthesia.
- The participant is known or suspected to have an anatomical malformation impeding a proper intubation.
- The participant is known or suspected to have a history of malignant hyperthermia.
- The participant is pregnant (or intends to become pregnant within the presurgical period) or lactating.
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 |
|---|---|---|
| sugammadex 2mg/kg | Drug | Repeated rocuronium dose - sugammadex, Single rocuronium dose - sugammadex |
| neostigmine | Drug | Repeated rocuronium dose - neostigmine |
| sugammadex 4mg/kg | Drug | Continuous rocuronium dose |
| placebo | Drug | Single rocuronium dose - placebo |
| Single rocuronium dose | Drug | Single rocuronium dose - placebo, Single rocuronium dose - sugammadex |
| Repeated rocuronium dose | Drug | Repeated rocuronium dose - neostigmine, Repeated rocuronium dose - sugammadex |
| Continuous rocuronium infusion | Drug | Continuous rocuronium dose |
Primary outcome
Electric Activity of the Diaphragm (Microvolts)
Time frame: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing
1 secondary outcome
Electric Activity of the Intercostal Muscles
Time frame: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23011532Dres M, Schmidt M, Ferre A, Mayaux J, Similowski T, Demoule A. Diaphragm electromyographic activity as a predictor of weaning failure. Intensive Care Med. 2012 Dec;38(12):2017-25. doi: 10.1007/s00134-012-2700-3. Epub 2012 Sep 26.
- Derived from this study: PubMed 31629404Schepens T, Janssens K, Maes S, Wildemeersch D, Vellinga J, Jorens PG, Saldien V. Respiratory muscle activity after spontaneous, neostigmine- or sugammadex-enhanced recovery of neuromuscular blockade: a double blind prospective randomized controlled trial. BMC Anesthesiol. 2019 Oct 19;19(1):187. doi: 10.1186/s12871-019-0863-y.
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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 3 study testing sugammadex 2mg/kg, neostigmine and sugammadex 4mg/kg in people with Diaphragmatic Dysfunction and Muscle Weakness, run by University Hospital, Antwerp at 1 site in Belgium.
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 6 inclusion and 14 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 24 Oct 2018. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Oct 2018). 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?
Electric Activity of the Diaphragm (Microvolts) (time frame: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing). 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 NCT01962298, 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 24 Oct 2018.