Neuromuscular Blockade MonitoringCURAREANCT07741851
Monitoring of Neuromuscular Blockade in the Intensive Care Unit: a Reliability Study
A study testing neuromuscular blockade monitoring in people with Neuromuscular Blockade Monitoring, run by Centre Hospitalier Intercommunal Aix-Pertuis at 1 site in France.
Trial summary
The objective of this clinical trial is to evaluate the reliability of neuromuscular blockade monitoring in adult intensive care patients depending on the clinical context. The main questions it aims to answer are as follows: Detection of an anomaly at ulnar "TOF" stimulation in patients without neuromuscular blockade… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade Monitoring
- What is being tested?
- neuromuscular blockade monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients admitted to the intensive care unit who have been receiving neuromuscular blocking agents for at least 24 hours during their stay - Consent obtained from the patient or emergency consent obtained from family members
- Patients covered by the French social security system, regardless of the specific plan
Who cannot join
- Patients who have already been exposed to prolonged neuromuscular blockade or who have been receiving continuous neuromuscular blockade for less than 24 hours
- Allergy to neuromuscular blocking agents
- Patients with a neurological condition that alters the interpretation of neuromuscular blockade or contraindicates the use of neuromuscular blocking agents
- Patients enrolled in an interventional study
- Patients who object to the collection of their medical data for this study
- Patients under the age of 18
- Patients deprived of their liberty, under guardianship, or under conservatorship
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, 13090
Clinical research manager, 04.42.33.56.50 ext. +33, rechercheclinique@ch-aix.fr
Romain Ronflé, Dr
About this study
The objective of this clinical trial is to evaluate the reliability of neuromuscular blockade monitoring in adult intensive care patients depending on the clinical context.
The main questions it aims to answer are as follows:
- Detection of an anomaly at ulnar "TOF" stimulation in patients without neuromuscular blockade
- Absence of adverse events during clinical monitoring of neuromuscular blockade (every 24 hours): absence of respiratory effort movements or patient-ventilator asynchrony (safety)
Read the detailed description
Muscle relaxation in the intensive care unit is a commonly used therapeutic approach, but one that remains controversial due to a debated benefit-risk ratio depending on the clinical context. First, neuromuscular blockade is a common technique in the operating room to facilitate orotracheal intubation or to improve surgical comfort during the procedure.
The French Society of Anesthesia and Intensive Care (SFAR) recommends intraoperative monitoring of neuromuscular blockade and recovery from neuromuscular blockade for patients under general anesthesia who have received neuromuscular blocking agents. It is recommended to use ulnar nerve stimulation at the wrist with visual or tactile assessment of thumb adductor contraction, given the ease of access as well as the potential to quantify the muscular response of this muscle. When deep neuromuscular blockade of the body's most resistant muscles (diaphragm, abdominal wall muscles) is indicated, it is recommended to wait until the four responses to the four-pulse train to the thumb adductor have disappeared and to monitor using Post-Tetanic Count (PTC) stimulation. In this case, the presence of one to five responses to the thumb adductor indicates complete paralysis of the abdominal muscles. Stimulation of the facial nerve in four-pulse trains and visual assessment of the response in the corrugator supercilii muscle is an alternative to the ulnar nerve test. The neuromuscular blockade profile of the corrugator supercilii muscle is comparable to that of the body's most resistant muscles, such as the laryngeal adductors or the diaphragm.
In the intensive care unit, neuromuscular blockade is primarily used for emergency orotracheal intubation and in cases of severe acute respiratory distress syndrome (ARDS). In moderate-to-severe cases, some patients require deep, continuous sedation during the initial phase, sometimes in combination with neuromuscular blockade. Early and continuous infusion of cisatracurium during the initial phase of severe ARDS (P/F < 150) has demonstrated a clear clinical benefit in terms of 90-day mortality through several pathophysiological mechanisms. However, prolonged use of neuromuscular blockade is also associated with neuromuscular weakness and requires deep sedation, which can itself have negative consequences. Despite the lack of robust evidence, monitoring of neuromuscular blockade is recommended in patients in the intensive care unit. Monitoring the depth of neuromuscular blockade would help ensure that neuromuscular blockade goals are met while using the lowest possible doses of neuromuscular blocking agents.
Clinical assessment based on observation of respiratory effort or detection of patient-ventilator asynchrony should be combined with a quantitative method for evaluating neuromuscular blockade: "Train-of-four" (TOF) or "post-tetanic count" (PTC) . However, no study has examined the feasibility of this technique in our intensive care patients across different clinical contexts. The data have been extrapolated from the operating room, even though the use of neuromuscular blockers in the ICU differs and certain clinical situations may make interpretation of the monitoring results potentially difficult: ICU-acquired neuromyopathy, therapeutic hypothermia, and interstitial edema.
These clinical situations may alter the muscle response to electrical stimulation and thus skew the results of "TOF" or "PTC" monitoring.
The objective of our study is to evaluate the reliability of neuromuscular blockade monitoring in intensive care patients.
- Conditions
- Neuromuscular Blockade Monitoring
- Being tested
- neuromuscular blockade monitoring
- Keywords
- intensive care, neuromusculare blockade monitoring, cisatracurium, TOF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular blockade monitoringDevice
The goal of monitoring neuromuscular blockade in an intensive care patient is to ensure the effectiveness of the technique through adequate neuromuscular blockade. In addition to a clinical assessment based on observation of respiratory effort or detection of patient-ventilator asynchrony, this monitoring includes the use of quantitative methods with TOFscan Idmed device to evaluate neuromuscular blockade: "TOF" and "PTC." The use of neuromuscular blocking agents and their monitoring are governed by a standard care protocol in each participating center. The investigators will study, within the context of routine care, the reliability and reproducibility of this technique, which was initially applied and validated in patients in the operating room and subsequently adapted for use in intensive care patients.
| Study group | Role | What they receive |
|---|---|---|
| monitoring of muscle relaxation | Experimental | Not described Receives: Device: neuromuscular blockade monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient.
TOF stimulation is one of the most commonly used types of stimulation; it consists of four stimuli (each lasting 200 μs) spaced 0.5 seconds apart. Without neuromuscular blockade, the expected answer in intensive care patients are 4 out of 4
Measured: From admission to discontinuation of sedation, for up to 15 days
Secondary outcomes (2)
Comparison of the response to ulnar "TOF" and "PTC" stimulation versus orbicularis "TOF" stimulation in patients under neuromuscular blockade (effectiveness)
The aim is to highlight a correlation between ulnar and orbicularis stimulation
Measured: From admission to discontinuation of sedation, for up to 15 days
Absence of adverse events during clinical monitoring of neuromuscular blockade:
absence of respiratory effort movements or patient-ventilator asynchrony (safety record)
Measured: From admission to discontinuation of sedation, for up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start2 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Blockade MonitoringStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-Pertuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Ronfle, Centre Hospitalier Intercommunal Aix-Pertuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741851
- Sponsor's protocol ID
- 2025-A02564-45
- Acronym
- CURAREA
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Neuromuscular Blockade in the Intensive Care Unit: a Reliability Study
- ClinicalTrials.gov ID
- NCT07741851
- Acronym / sponsor ID
- CURAREA / 2025-A02564-45
- Conditions
- Neuromuscular Blockade Monitoring
- Keywords
- intensive care, neuromusculare blockade monitoring, cisatracurium, TOF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-PertuisUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Aug 2026 (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 objective of this clinical trial is to evaluate the reliability of neuromuscular blockade monitoring in adult intensive care patients depending on the clinical context.
The main questions it aims to answer are as follows:
- Detection of an anomaly at ulnar "TOF" stimulation in patients without neuromuscular blockade
- Absence of adverse events during clinical monitoring of neuromuscular blockade (every 24 hours): absence of respiratory effort movements or patient-ventilator asynchrony (safety)
Detailed description
Muscle relaxation in the intensive care unit is a commonly used therapeutic approach, but one that remains controversial due to a debated benefit-risk ratio depending on the clinical context. First, neuromuscular blockade is a common technique in the operating room to facilitate orotracheal intubation or to improve surgical comfort during the procedure.
The French Society of Anesthesia and Intensive Care (SFAR) recommends intraoperative monitoring of neuromuscular blockade and recovery from neuromuscular blockade for patients under general anesthesia who have received neuromuscular blocking agents. It is recommended to use ulnar nerve stimulation at the wrist with visual or tactile assessment of thumb adductor contraction, given the ease of access as well as the potential to quantify the muscular response of this muscle. When deep neuromuscular blockade of the body's most resistant muscles (diaphragm, abdominal wall muscles) is indicated, it is recommended to wait until the four responses to the four-pulse train to the thumb adductor have disappeared and to monitor using Post-Tetanic Count (PTC) stimulation. In this case, the presence of one to five responses to the thumb adductor indicates complete paralysis of the abdominal muscles. Stimulation of the facial nerve in four-pulse trains and visual assessment of the response in the corrugator supercilii muscle is an alternative to the ulnar nerve test. The neuromuscular blockade profile of the corrugator supercilii muscle is comparable to that of the body's most resistant muscles, such as the laryngeal adductors or the diaphragm.
In the intensive care unit, neuromuscular blockade is primarily used for emergency orotracheal intubation and in cases of severe acute respiratory distress syndrome (ARDS). In moderate-to-severe cases, some patients require deep, continuous sedation during the initial phase, sometimes in combination with neuromuscular blockade. Early and continuous infusion of cisatracurium during the initial phase of severe ARDS (P/F < 150) has demonstrated a clear clinical benefit in terms of 90-day mortality through several pathophysiological mechanisms. However, prolonged use of neuromuscular blockade is also associated with neuromuscular weakness and requires deep sedation, which can itself have negative consequences. Despite the lack of robust evidence, monitoring of neuromuscular blockade is recommended in patients in the intensive care unit. Monitoring the depth of neuromuscular blockade would help ensure that neuromuscular blockade goals are met while using the lowest possible doses of neuromuscular blocking agents.
Clinical assessment based on observation of respiratory effort or detection of patient-ventilator asynchrony should be combined with a quantitative method for evaluating neuromuscular blockade: "Train-of-four" (TOF) or "post-tetanic count" (PTC) . However, no study has examined the feasibility of this technique in our intensive care patients across different clinical contexts. The data have been extrapolated from the operating room, even though the use of neuromuscular blockers in the ICU differs and certain clinical situations may make interpretation of the monitoring results potentially difficult: ICU-acquired neuromyopathy, therapeutic hypothermia, and interstitial edema.
These clinical situations may alter the muscle response to electrical stimulation and thus skew the results of "TOF" or "PTC" monitoring.
The objective of our study is to evaluate the reliability of neuromuscular blockade monitoring in intensive care patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monitoring of muscle relaxation | Experimental | Device: neuromuscular blockade monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Patients admitted to the intensive care unit who have been receiving neuromuscular blocking agents for at least 24 hours during their stay - Consent obtained from the patient or emergency consent obtained from family members
- Patients covered by the French social security system, regardless of the specific plan
Key exclusion criteria (8 listed)
- Patients who have already been exposed to prolonged neuromuscular blockade or who have been receiving continuous neuromuscular blockade for less than 24 hours
- Allergy to neuromuscular blocking agents
- Patients with a neurological condition that alters the interpretation of neuromuscular blockade or contraindicates the use of neuromuscular blocking agents
- Patients enrolled in an interventional study
- Patients who object to the collection of their medical data for this study
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 |
|---|---|---|
| neuromuscular blockade monitoringThe goal of monitoring neuromuscular blockade in an intensive care patient is to ensure the effectiveness of the technique through adequate neuromuscular blockade. In addition to a clinical assessment based on observation of respiratory effort or detection of patient-ventilator asynchrony, this monitoring includes the use of quantitative methods with TOFscan Idmed device to evaluate neuromuscular blockade: "TOF" and "PTC." The use of neuromuscular blocking agents and their monitoring are governed by a standard care protocol in each participating center. The investigators will study, within the context of routine care, the reliability and reproducibility of this technique, which was initially applied and validated in patients in the operating room and subsequently adapted for use in intensive care patients. | Device | monitoring of muscle relaxation |
Primary outcome
Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient.
Time frame: From admission to discontinuation of sedation, for up to 15 days
TOF stimulation is one of the most commonly used types of stimulation; it consists of four stimuli (each lasting 200 μs) spaced 0.5 seconds apart. Without neuromuscular blockade, the expected answer in intensive care patients are 4 out of 4
2 secondary outcomes
Comparison of the response to ulnar "TOF" and "PTC" stimulation versus orbicularis "TOF" stimulation in patients under neuromuscular blockade (effectiveness)
Time frame: From admission to discontinuation of sedation, for up to 15 days
Absence of adverse events during clinical monitoring of neuromuscular blockade:
Time frame: From admission to discontinuation of sedation, for up to 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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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.
Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular blockade monitoring in people with Neuromuscular Blockade Monitoring, run by Centre Hospitalier Intercommunal Aix-Pertuis 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient. (time frame: From admission to discontinuation of sedation, for up to 15 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 3 Aug 2026.