AnesthesiaDBS PREDICTIONNCT02893436
Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation
An observational study of Anesthesia and Surgery, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgery
- What is being tested?
- Surgery with tracheal intubation curarisation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Sep 2016
- Phase
- Observational
- 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
Study population: Patient curarised at Nancy Hospital
Who may be able to join
- ASA score 1-3
- Needing a surgery with tracheal intubation curarisation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Denis Schmartz contact
About this study
The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.
Read the detailed description
Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery:
- T4/T1 ratio: ratio between the 4th and 1st response to "train of four" stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is > 0.9
- Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms.
It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is > 0.6. However, for an optimal recovery, T4/T1 ratio must be > 0.9.
This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation.
Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.
- Conditions
- Anesthesia, Surgery
- Being tested
- Surgery with tracheal intubation curarisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with tracheal intubation curarisationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Curarized patients | Not described Receives: Procedure: Surgery with tracheal intubation curarisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9
measured with TOF-Watch Sx
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Schmartz, Principal investigator, CHRU Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893436
- Sponsor's protocol ID
- PSS2014/DBSPREDICTION-SCHMARTZ
- Acronym
- DBS PREDICTION
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation
- ClinicalTrials.gov ID
- NCT02893436
- Acronym / sponsor ID
- DBS PREDICTION / PSS2014/DBSPREDICTION-SCHMARTZ
- Conditions
- Anesthesia, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 8 Sep 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 calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.
Detailed description
Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery:
- T4/T1 ratio: ratio between the 4th and 1st response to "train of four" stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is > 0.9
- Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms.
It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is > 0.6. However, for an optimal recovery, T4/T1 ratio must be > 0.9.
This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation.
Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curarized patients | – | Procedure: Surgery with tracheal intubation curarisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient curarised at Nancy Hospital
Key inclusion criteria (2 listed)
- ASA score 1-3
- Needing a surgery with tracheal intubation curarisation
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Surgery with tracheal intubation curarisation | Procedure or surgery | Curarized patients |
Primary outcome
Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9
Time frame: day 0
measured with TOF-Watch Sx
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Denis Schmartz contact
Denis Schmartz principal investigator
CHRU Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Surgery, 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 2 inclusion and 1 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 8 Sep 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 Denis Schmartz (d.schmartz@chru-nancu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9 (time frame: day 0). 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 8 Sep 2016.