Complication of Ventilation TherapyNCT02318810
Influence of the Neuromuscular Blockade on Mask Ventilation
A study testing Rocuronium 0.3 mg/kg, Rocuronium 0.6 mg/kg and Rocuronium 0.9 mg/kg in people with Complication of Ventilation Therapy and Observation of Neuromuscular Block, run by University of Rostock at 1 site in Germany.
Trial summary
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complication of Ventilation Therapy, Observation of Neuromuscular Block
- What is being tested?
- Rocuronium 0.3 mg/kg, Rocuronium 0.6 mg/kg and Rocuronium 0.9 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to May 2016
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with ASA I-III
- required tracheal intubation
- informed consent
Who cannot join
- known allergy against anesthetics
- known difficult airway
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesia and Intensive Care Medicine, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Official title: The Influence of the Neuromuscular Blockade on Mask Ventilation; a Placebo Controlled, Randomized Trial With Three Different Dosages of Rocuronium (0.3 mg/kg, 0.6 mg/kg and 0.9 mg/kg)
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation. We will study different dosages of rocuronium; we assume that higher dosages of rocuronium will improve mask ventilation compared with lower dosages.
Read the detailed description
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and saline (placebo group) before starting with mask ventilation. We will grade mask ventilation based on various scores before and after rocuronium application. Afterwards patient's tracheas will be intubated. We assess risk factors for difficult mask ventilation.
We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.
- Being tested
- Rocuronium 0.3 mg/kg, Rocuronium 0.6 mg/kg, Rocuronium 0.9 mg/kg, Placebo
- Keywords
- Muscle relaxants
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium 0.3 mg/kgDrug
Also called Esmeron
Patients receive rocuronium 0.3 mg/kg
Rocuronium 0.6 mg/kgDrug
Also called Esmeron
Patients receive rocuronium 0.6 mg/kg
Rocuronium 0.9 mg/kgDrug
Also called Esmeron
Patients receive rocuronium 0.9 mg/kg
PlaceboDrug
Also called Saline
Patients receive saline
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium 0.3 mg/kg | Active comparator | Patients receive rocuronium 0.3 mg/kg Receives: Drug: Rocuronium 0.3 mg/kg |
| Rocuronium 0.6 mg/kg | Active comparator | Patients receive rocuronium 0.6 mg/kg Receives: Drug: Rocuronium 0.6 mg/kg |
| Rocuronium 0.9 mg/kg | Active comparator | Patients receive rocuronium 0.9 mg/kg Receives: Drug: Rocuronium 0.9 mg/kg |
| Placebo | Placebo comparator | Patients receive saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of improved mask ventilation after rocuronium administration
Graded with various scores
Measured: Two minutes after rocuronium administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Ventilation TherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mencke, University of Rostock
- Investigators
- Thomas Mencke, Prof., Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318810
- Sponsor's protocol ID
- A 2014 1212
- Status last verified
- May 2016
- First submitted
- 12 Dec 2014
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Neuromuscular Blockade on Mask Ventilation; a Placebo Controlled, Randomized Trial With Three Different Dosages of Rocuronium (0.3 mg/kg, 0.6 mg/kg and 0.9 mg/kg)
- ClinicalTrials.gov ID
- NCT02318810
- Acronym / sponsor ID
- A 2014 1212
- Keywords
- Muscle relaxants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Dec 2014 (estimated)
- 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.
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation. We will study different dosages of rocuronium; we assume that higher dosages of rocuronium will improve mask ventilation compared with lower dosages.
Detailed description
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and saline (placebo group) before starting with mask ventilation. We will grade mask ventilation based on various scores before and after rocuronium application. Afterwards patient's tracheas will be intubated. We assess risk factors for difficult mask ventilation.
We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rocuronium 0.3 mg/kg | Active comparator | Drug: Rocuronium 0.3 mg/kgPatients receive rocuronium 0.3 mg/kg |
| Rocuronium 0.6 mg/kg | Active comparator | Drug: Rocuronium 0.6 mg/kgPatients receive rocuronium 0.6 mg/kg |
| Rocuronium 0.9 mg/kg | Active comparator | Drug: Rocuronium 0.9 mg/kgPatients receive rocuronium 0.9 mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with ASA I-III
- required tracheal intubation
- informed consent
Key exclusion criteria (2 listed)
- known allergy against anesthetics
- known difficult airway
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 |
|---|---|---|
| Rocuronium 0.3 mg/kgAlso: EsmeronPatients receive rocuronium 0.3 mg/kg | Drug | Rocuronium 0.3 mg/kg |
| Rocuronium 0.6 mg/kgAlso: EsmeronPatients receive rocuronium 0.6 mg/kg | Drug | Rocuronium 0.6 mg/kg |
| Rocuronium 0.9 mg/kgAlso: EsmeronPatients receive rocuronium 0.9 mg/kg | Drug | Rocuronium 0.9 mg/kg |
| PlaceboAlso: SalinePatients receive saline | Drug | Placebo |
Primary outcome
Incidence of improved mask ventilation after rocuronium administration
Time frame: Two minutes after rocuronium administration
Graded with various scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Mencke, Prof. principal investigator
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium 0.3 mg/kg, Rocuronium 0.6 mg/kg and Rocuronium 0.9 mg/kg in people with Complication of Ventilation Therapy and Observation of Neuromuscular Block, run by University of Rostock at 1 site in Germany.
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 3 inclusion and 2 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 3 May 2016. 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 Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of improved mask ventilation after rocuronium administration (time frame: Two minutes after rocuronium administration). 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 3 May 2016.