Observation of Neuromuscular BlockCurHaTOFNCT02825121
Evaluation of Monitoring Neuromuscular Blockade the Flexor Hallucis Compared to the Adductor Pollicis
A study testing Monitoring Neuromuscular Blockade the Flexor Hallucis and Monitoring Neuromuscular Blockade adductor of the thumb. in people with Observation of Neuromuscular Block and Flexor Hallucis, run by Poitiers University Hospital at 1 site in France.
Trial summary
Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist. However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observation of Neuromuscular Block, Flexor Hallucis, Adductor Pollicis
- What is being tested?
- Monitoring Neuromuscular Blockade the Flexor Hallucis and Monitoring Neuromuscular Blockade adductor of the thumb.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Sep 2017
- 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
- over 18 years
- Any elective surgery with single or multiple injection Atracurium for which hand and foot are accessible at the same time.
- ASA I or II patients
- free subject, without guardianship or subordination
- No opposition given by the patient after information
Who cannot join
- under 18 years
- known neuromyopathy
- Diabetics
- Emergency surgery and a full stomach
- predictable difficult intubation
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist.
However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient.
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To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist.
The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention.
The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis.
The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis.
This is a prospective, exploratory, uncontrolled, single-center for routine care.
Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .
- Being tested
- Monitoring Neuromuscular Blockade the Flexor Hallucis, Monitoring Neuromuscular Blockade adductor of the thumb.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring Neuromuscular Blockade the Flexor HallucisDevice
Monitoring Neuromuscular Blockade adductor of the thumb.Device
| Study group | Role | What they receive |
|---|---|---|
| Monitoring Neuromuscular Blockade | Experimental | Monitoring Neuromuscular Blockade the Flexor Hallucis and adductor of the thumb. Receives: Device: Monitoring Neuromuscular Blockade the Flexor Hallucis; Device: Monitoring Neuromuscular Blockade adductor of the thumb. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of occurrence of a T4 / T1 ratio> 0.90 in the train of four flexor hallucis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Observation of Neuromuscular BlockStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02825121
- Sponsor's protocol ID
- CURHATOF
- Acronym
- CurHaTOF
- Status last verified
- Oct 2016
- First submitted
- 4 Jul 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
Publications
Le Merrer M, Frasca D, Dupuis M, Debaene B, Boisson M. A comparison between the flexor hallucis brevis and adductor pollicis muscles in atracurium-induced neuromuscular blockade using acceleromyography: A prospective observational study. Eur J Anaesthesiol. 2020 Jan;37(1):38-43. doi: 10.1097/EJA.0000000000001090.
PubMed 31592900
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Monitoring Neuromuscular Blockade the Flexor Hallucis Compared to the Adductor Pollicis
- ClinicalTrials.gov ID
- NCT02825121
- Acronym / sponsor ID
- CurHaTOF / CURHATOF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Jul 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.
Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist.
However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient.
To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist.
The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention.
The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis.
The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis.
This is a prospective, exploratory, uncontrolled, single-center for routine care.
Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring Neuromuscular Blockade | Experimental | Device: Monitoring Neuromuscular Blockade the Flexor Hallucis, Device: Monitoring Neuromuscular Blockade adductor of the thumb.Monitoring Neuromuscular Blockade the Flexor Hallucis and adductor of the thumb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 18 years
- Any elective surgery with single or multiple injection Atracurium for which hand and foot are accessible at the same time.
- ASA I or II patients
- free subject, without guardianship or subordination
- No opposition given by the patient after information
Key exclusion criteria (6 listed)
- under 18 years
- known neuromyopathy
- Diabetics
- Emergency surgery and a full stomach
- predictable difficult intubation
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 |
|---|---|---|
| Monitoring Neuromuscular Blockade the Flexor Hallucis | Device | Monitoring Neuromuscular Blockade |
| Monitoring Neuromuscular Blockade adductor of the thumb. | Device | Monitoring Neuromuscular Blockade |
Primary outcome
Time of occurrence of a T4 / T1 ratio> 0.90 in the train of four flexor hallucis
Time frame: 1 day
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 5 Oct 2017.
- Derived from this study: PubMed 31592900Le Merrer M, Frasca D, Dupuis M, Debaene B, Boisson M. A comparison between the flexor hallucis brevis and adductor pollicis muscles in atracurium-induced neuromuscular blockade using acceleromyography: A prospective observational study. Eur J Anaesthesiol. 2020 Jan;37(1):38-43. doi: 10.1097/EJA.0000000000001090.
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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 Neuromuscular Blockade the Flexor Hallucis and Monitoring Neuromuscular Blockade adductor of the thumb. in people with Observation of Neuromuscular Block and Flexor Hallucis, 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 6 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 5 Oct 2017. 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?
Time of occurrence of a T4 / T1 ratio> 0.90 in the train of four flexor hallucis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825121, which also lists 1 linked publication.
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 5 Oct 2017.