CurarisationTOFScanNCT02880787
Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®
A study testing Rocuronium and Neuromuscular monitoring with TOFScan® and TOF-Watch SX® in people with Curarisation and Neuromuscular Monitoring, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Curarisation, Neuromuscular Monitoring
- What is being tested?
- Rocuronium and Neuromuscular monitoring with TOFScan® and TOF-Watch SX®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Dec 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult population:
- Non opposition to research
- > 18 years old
- ASA score 1-3
- Undergoing surgery with curarisation through tracheal intubation
- Affiliation to social security
Show all 12Show fewer
- Pediatric population:
- > 1 year old
- Non opposition to research of child (if able to consent) or representatives with parental authority
- ASA score 1-4
- Undergoing surgery with curarisation
- Affiliation to social security
Who cannot join
- Adult population:
- Allergy to administered drugs
- Known or suspected difficult intubation
- Pregnant women
- BMI > 40
- Pediatric population:
- Allergy to administered drugs
- Known or suspected difficult intubation
Trial locations and contacts
1 site in 1 country.
Thomas FUCHS-BUDER, Pr contact
France1 site, 1 recruiting
- Recruiting
CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation
Vandœuvre-lès-Nancy
About this study
The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.
Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:
- the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
- the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
- recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
- complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.
- Conditions
- Curarisation, Neuromuscular Monitoring
- Being tested
- Rocuronium, Neuromuscular monitoring with TOFScan® and TOF-Watch SX®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)
Neuromuscular monitoring with TOFScan® and TOF-Watch SX®Device
Each monitor on one arm
| Study group | Role | What they receive |
|---|---|---|
| Adult population 1 | Other | TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm Receives: Drug: Rocuronium; Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® |
| Adult population 2 | Other | TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm Receives: Drug: Rocuronium; Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® |
| Pediatric population 1 | Other | TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm Receives: Drug: Rocuronium; Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® |
| Pediatric population 2 | Other | TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm Receives: Drug: Rocuronium; Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Secondary outcomes (2)
Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX
Measured: day 0, after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CurarisationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas FUCHS-BUDER, Pr, Principal investigator, CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation - VANDOEUVRE LES NANCY - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880787
- Sponsor's protocol ID
- 2014-A00540-47
- Acronym
- TOFScan
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®
- ClinicalTrials.gov ID
- NCT02880787
- Acronym / sponsor ID
- TOFScan / 2014-A00540-47
- Conditions
- Curarisation, Neuromuscular Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Aug 2016 (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.
The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.
Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:
- the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
- the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
- recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
- complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult population 1 | Other | Drug: Rocuronium, Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm |
| Adult population 2 | Other | Drug: Rocuronium, Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm |
| Pediatric population 1 | Other | Drug: Rocuronium, Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm |
| Pediatric population 2 | Other | Drug: Rocuronium, Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Non opposition to research
- > 18 years old
- ASA score 1-3
- Undergoing surgery with curarisation through tracheal intubation
- Affiliation to social security
Key exclusion criteria (8 listed)
- Allergy to administered drugs
- Known or suspected difficult intubation
- Pregnant women
- BMI > 40
- Allergy to administered drugs
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 |
|---|---|---|
| RocuroniumAnesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg) | Drug | Adult population 1, Adult population 2, Pediatric population 1, Pediatric population 2 |
| Neuromuscular monitoring with TOFScan® and TOF-Watch SX®Each monitor on one arm | Device | Adult population 1, Adult population 2, Pediatric population 1, Pediatric population 2 |
Primary outcome
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
2 secondary outcomes
Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX
Time frame: day 0, after induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
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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 FUCHS-BUDER, Pr contact
Thomas FUCHS-BUDER, Pr principal investigator
CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation - VANDOEUVRE LES NANCY - 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 Rocuronium and Neuromuscular monitoring with TOFScan® and TOF-Watch SX® in people with Curarisation and Neuromuscular Monitoring, run by Central Hospital, Nancy, France 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 12 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: status not confirmed, as of the sponsor's last update on 26 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas FUCHS-BUDER, Pr (t.fuchs-buder@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX (time frame: day 0, after induction of anesthesia). The study lists 8 primary outcomes in all. 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 26 Aug 2016.