Critical IllnessPhase 3NCT03198637
Comparison of Neuromuscular Blockade's Monitoring and Clinical Assessment During Cisatracurium Paralysis in Critically Ill Patients
A Phase 3 study testing Cisatracurium's monitoring by TOF (train-of-four) WATCH device. and clinical assessment in people with Critical Illness, run by Poitiers University Hospital at 1 site in France.
Trial summary
The main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression. The use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Cisatracurium's monitoring by TOF (train-of-four) WATCH device. and clinical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to May 2018
- Phase
- Phase 3
- 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
- Age over 18 years
- Mechanically ventilated patients
- Indication for prescribing curare extended less than 1 day
- Sedation
- Information form waived by family members or surrogates
Who cannot join
- Pregnancy,
- Curare infusion ongoing
- Neuromuscular disorders
- Dermal alteration
- Allergy to cisatracurium, atracurium, benzene sulfonic acid
- Expected survival of less than 2 days
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- Personal or family history of malignant hyperthermia
- No social security
- Patient under enhanced protection
- Patient participating to an other intervention research or participated within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression.
The use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. Its interest is subject to a recommendation grade B and its use in prevention of overdose is associated with a recommendation of Grade C.
Read more
However, many practitioners continue to objectify the depth of neuromuscular blockade and reversal by simple clinical evaluation. This is a subjective estimate of the depth of neuromuscular block.
Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug distribution volume is usually increased in the Intensive Care patient and requires an increase in initial doses to obtain the same pharmacological effect.
Then, unlike a short-term administration, the administration of neuromuscular blocking agents on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower which contributes to the increase of the elimination period after interruption of the administration of curare. There is therefore a risk of residual paralysis.
Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte disorders and acid-base, administration of certain drugs, the inter- and intra-individual variability and tachyphylaxis (form tolerance of particularly rapid installation during a few close administration, linked to the proliferation of cholinergic receptors).
The value of monitoring neuromuscular blockade in intensive care is the prevention of overdose and in finding the lowest effective dose.
- Conditions
- Critical Illness
- Being tested
- Cisatracurium's monitoring by TOF (train-of-four) WATCH device., clinical assessment
- Keywords
- efficient, neuromuscular, blockade
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisatracurium's monitoring by TOF (train-of-four) WATCH device.Drug
Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.
clinical assessmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Monitoring | Experimental | Neuromuscular Blockade's monitoring Receives: Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device. |
| Clinical assessment | Active comparator | No active monitoring of cisatracurium Receives: Drug: clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of individual cumulative dose in mg cisatracurium
Measured: through study completion : from 1 to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study startApr 2013
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT03198637
- Sponsor's protocol ID
- MONITOR
- Status last verified
- May 2018
- First submitted
- 10 Jun 2016
- Last updated
- 31 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Neuromuscular Blockade's Monitoring and Clinical Assessment During Cisatracurium Paralysis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03198637
- Acronym / sponsor ID
- MONITOR
- Conditions
- Critical Illness
- Keywords
- efficient, neuromuscular, blockade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 Jun 2017 (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.
The main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression.
The use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. Its interest is subject to a recommendation grade B and its use in prevention of overdose is associated with a recommendation of Grade C.
However, many practitioners continue to objectify the depth of neuromuscular blockade and reversal by simple clinical evaluation. This is a subjective estimate of the depth of neuromuscular block.
Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug distribution volume is usually increased in the Intensive Care patient and requires an increase in initial doses to obtain the same pharmacological effect.
Then, unlike a short-term administration, the administration of neuromuscular blocking agents on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower which contributes to the increase of the elimination period after interruption of the administration of curare. There is therefore a risk of residual paralysis.
Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte disorders and acid-base, administration of certain drugs, the inter- and intra-individual variability and tachyphylaxis (form tolerance of particularly rapid installation during a few close administration, linked to the proliferation of cholinergic receptors).
The value of monitoring neuromuscular blockade in intensive care is the prevention of overdose and in finding the lowest effective dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring | Experimental | Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device.Neuromuscular Blockade's monitoring |
| Clinical assessment | Active comparator | Drug: clinical assessmentNo active monitoring of cisatracurium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Mechanically ventilated patients
- Indication for prescribing curare extended less than 1 day
- Sedation
- Information form waived by family members or surrogates
Key exclusion criteria (10 listed)
- Pregnancy,
- Curare infusion ongoing
- Neuromuscular disorders
- Dermal alteration
- Allergy to cisatracurium, atracurium, benzene sulfonic acid
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 |
|---|---|---|
| Cisatracurium's monitoring by TOF (train-of-four) WATCH device.Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device. | Drug | Monitoring |
| clinical assessment | Drug | Clinical assessment |
Primary outcome
Reduction of individual cumulative dose in mg cisatracurium
Time frame: through study completion : from 1 to 20 days
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 31 May 2018.
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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 Cisatracurium's monitoring by TOF (train-of-four) WATCH device. and clinical assessment in people with Critical Illness, 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 10 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 31 May 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 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.
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?
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?
Reduction of individual cumulative dose in mg cisatracurium (time frame: through study completion : from 1 to 20 days). 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 31 May 2018.