LaryngoscopyMONITURARENCT03981042
Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)
A study testing Monitoring in people with Laryngoscopy and Anesthesic Aduction, run by Poitiers University Hospital at 1 site in France.
Trial summary
During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngoscopy, Anesthesic Aduction, Neuromuscular Blockade
- What is being tested?
- Monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2019to 2 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years), both sexes
- Any elective surgery requiring injection of atracurium
- Free patient, without guardianship or subordination
- Patients with a social security coverage
- Informed and signed consent after clear and fair information
Who cannot join
- Rapid sequence induction
- Predictable difficult intubation
- Use of a neuromuscular blockade agent other than atracurium
- Known contraindication to a neuromuscular blockade agent
Trial locations and contacts
1 site in 1 country.
About this study
During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. However, many studies have shown a large inter-individual variability on the delay of the NMB onset. The main objective of othe investigator's study is to compare the quality of laryngoscopy during intubation between the NMB onset monitoring and the expectation of a fixed delay after curarization
Read the detailed description
French guidelines on curarization, updated in 2018, do not recommend the NMB onset monitoring due to a lack of data in the literature. Thus, the interest of monitoring cannot be asserted and its superiority over waiting for a fixed delay has not been proven.
Due to a large inter-individual variability on the delay of the NMB onset after administration of atracurium, the relevance of monitoring NMB during an anesthetic induction should be assessed to improve the quality of laryngoscopy.
In case of monitoring, the experts recommend monitoring the NMB onset at the corrugator supercilli because it reflects neuromuscular blockade at the laryngeal adductor muscles.
During the pre-anaesthetic visit, patients will be enrolled after inform consent.
Patients will be randomized in two groups, control group (waiting for a 3-minute delay after injection of atracurium) or monitoring group (waiting for the TOF ratio at 0 at the corrugator supercilli).
Anesthetic induction will be performed with sufentanil, propofol and atracurium. After laryngoscopy, the primary outcome will be evaluated using Copenhagen score.
Patients will be followed up until they leave the recovery room..
- Conditions
- Laryngoscopy, Anesthesic Aduction, Neuromuscular Blockade, Monitoring
- Being tested
- Monitoring
- Keywords
- laryngoscopy, anesthesic aduction, neuromuscular blockade monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringDevice
After the anesthetic induction with sufentanil, propofol and atracurium, patients will be ventilated with mask until:
- Monitoring group: TOF ratio at the corrugator supercilli will be measured every 15 s after injection of atracurium. When TOF ratio reach 0, laryngoscopy with intubation will be performed
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | waiting for a 3-minute delay after injection of the atracurium before laryngoscopy |
| Monitoring group | Experimental | waiting for the TOF ratio at 0 at the corrugator supercilli before laryngoscopy Receives: Device: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
Measured: Few minutes after intubation (about 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start14 Jun 2019
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngoscopyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981042
- Sponsor's protocol ID
- 2019-A00667-50
- Acronym
- MONITURARE
- Status last verified
- Oct 2019
- First submitted
- 24 Apr 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)
- ClinicalTrials.gov ID
- NCT03981042
- Acronym / sponsor ID
- MONITURARE / 2019-A00667-50
- Conditions
- Laryngoscopy, Anesthesic Aduction, Neuromuscular Blockade, Monitoring
- Keywords
- laryngoscopy, anesthesic aduction, neuromuscular blockade monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 10 Jun 2019 (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.
During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. However, many studies have shown a large inter-individual variability on the delay of the NMB onset. The main objective of othe investigator's study is to compare the quality of laryngoscopy during intubation between the NMB onset monitoring and the expectation of a fixed delay after curarization
Detailed description
French guidelines on curarization, updated in 2018, do not recommend the NMB onset monitoring due to a lack of data in the literature. Thus, the interest of monitoring cannot be asserted and its superiority over waiting for a fixed delay has not been proven.
Due to a large inter-individual variability on the delay of the NMB onset after administration of atracurium, the relevance of monitoring NMB during an anesthetic induction should be assessed to improve the quality of laryngoscopy.
In case of monitoring, the experts recommend monitoring the NMB onset at the corrugator supercilli because it reflects neuromuscular blockade at the laryngeal adductor muscles.
During the pre-anaesthetic visit, patients will be enrolled after inform consent.
Patients will be randomized in two groups, control group (waiting for a 3-minute delay after injection of atracurium) or monitoring group (waiting for the TOF ratio at 0 at the corrugator supercilli).
Anesthetic induction will be performed with sufentanil, propofol and atracurium. After laryngoscopy, the primary outcome will be evaluated using Copenhagen score.
Patients will be followed up until they leave the recovery room..
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –waiting for a 3-minute delay after injection of the atracurium before laryngoscopy |
| Monitoring group | Experimental | Device: Monitoringwaiting for the TOF ratio at 0 at the corrugator supercilli before laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years), both sexes
- Any elective surgery requiring injection of atracurium
- Free patient, without guardianship or subordination
- Patients with a social security coverage
- Informed and signed consent after clear and fair information
Key exclusion criteria (4 listed)
- Rapid sequence induction
- Predictable difficult intubation
- Use of a neuromuscular blockade agent other than atracurium
- Known contraindication to a neuromuscular blockade agent
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 |
|---|---|---|
| MonitoringAfter the anesthetic induction with sufentanil, propofol and atracurium, patients will be ventilated with mask until: - Monitoring group: TOF ratio at the corrugator supercilli will be measured every 15 s after injection of atracurium. When TOF ratio reach 0, laryngoscopy with intubation will be performed | Device | Monitoring group |
Primary outcome
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
Time frame: Few minutes after intubation (about 5 minutes)
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
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 21 Oct 2019.
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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 study testing Monitoring in people with Laryngoscopy and Anesthesic Aduction, run by Poitiers University Hospital at 1 site in France.
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 5 inclusion and 4 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 21 Oct 2019. 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 France. 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.
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?
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation. (time frame: Few minutes after intubation (about 5 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 21 Oct 2019.