PhysiopathologyPhase 4CURARESNCT02004015
Assessment Study of the Effect of NMBA on Bowel Peristalsis
A Phase 4 study testing injection of NMBA in people with Physiopathology, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction. Primary End Point: proportion of patients with a score of motion = 0 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiopathology
- What is being tested?
- injection of NMBA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Apr 2015
- Phase
- Phase 4
- 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
- elective surgery
- scheduled oro tracheal intubation
Who cannot join
- Counter indication to NMBA:
- predicted difficult airway
- surgical counter indication: facial or laryngeal nerve function monitoring
- allergy to muscle relaxants neuro muscular disease Possible alteration of sensitivity to muscle relaxants due to ongoing medication: ex Valproate or aminoglycoside antibiotics. Predictable alteration of bowel movements or difficult abdominal ultrasound:
- scheduled abdominal surgery
- abdominal surgery in last month
- obesity: body mass index over 30 Full stomach or pregnancy requiring suxamethonium for intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.
Primary End Point: proportion of patients with a score of motion = 0
Read the detailed description
Primary End Point Proportion of patients with a score of motion = 0
Secondary End Point Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0) Mean minimal twitch measurement for those patients in who twitch measurement does not disappear Concordance study between twitch measurement and bowel peristalsis XML File Identifier: 1vUwHz2uUXeSc7soLu1cQwRAfcM= Page 15/24 ultrasound score.
- Conditions
- Physiopathology
- Being tested
- injection of placebo, injection of NMBA
- Keywords
- Analytical, Diagnostic, Anesthesia, Analgesia
- Medical subject headings
- Disease, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of placeboDrug
0.5 mg/kg milligram(s)/kilogram
injection of NMBADrug
| Study group | Role | What they receive |
|---|---|---|
| Atracurium | Experimental | injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use Receives: Drug: injection of NMBA |
| ROCURONIUM | Experimental | injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus Receives: Drug: injection of NMBA |
| placebo | Placebo comparator | injection of placebo Injection in Intravenous bolus use Receives: Drug: injection of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a score of motion = 0
Proportion of patients with a score of motion = 0
Measured: 10 minutes after NMBA or placebo injection
Secondary outcomes (1)
Time at which thumb adductor twitch measurement disappears
Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0). Mean minimal twitch measurement for those patients in who twitch measurement does not disappear. Concordance study between twitch measurement and bowel peristalsis
Measured: 1 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiopathologyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Guillaume Taylor, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004015
- Sponsor's protocol ID
- RBM_WTR_2012-9
- Acronym
- CURARES
- Status last verified
- Mar 2015
- First submitted
- 3 Dec 2013
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.
- ClinicalTrials.gov ID
- NCT02004015
- Acronym / sponsor ID
- CURARES / RBM_WTR_2012-9
- Conditions
- Physiopathology
- Keywords
- Analytical, Diagnostic, Anesthesia, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- First posted
- 6 Dec 2013 (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.
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.
Primary End Point: proportion of patients with a score of motion = 0
Detailed description
Primary End Point Proportion of patients with a score of motion = 0
Secondary End Point Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0) Mean minimal twitch measurement for those patients in who twitch measurement does not disappear Concordance study between twitch measurement and bowel peristalsis XML File Identifier: 1vUwHz2uUXeSc7soLu1cQwRAfcM= Page 15/24 ultrasound score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atracurium | Experimental | Drug: injection of NMBAinjection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use |
| ROCURONIUM | Experimental | Drug: injection of NMBAinjection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus |
| placebo | Placebo comparator | Drug: injection of placeboinjection of placebo Injection in Intravenous bolus use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective surgery
- scheduled oro tracheal intubation
Key exclusion criteria (7 listed)
- predicted difficult airway
- surgical counter indication: facial or laryngeal nerve function monitoring
- allergy to muscle relaxants neuro muscular disease Possible alteration of sensitivity to muscle relaxants due to ongoing medication: ex Valproate or aminoglycoside antibiotics. Predictable alteration of bowel movements or difficult abdominal ultrasound:
- scheduled abdominal surgery
- abdominal surgery in last month
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 |
|---|---|---|
| injection of placebo0.5 mg/kg milligram(s)/kilogram | Drug | placebo |
| injection of NMBA | Drug | Atracurium, ROCURONIUM |
Primary outcome
Proportion of patients with a score of motion = 0
Time frame: 10 minutes after NMBA or placebo injection
Proportion of patients with a score of motion = 0
1 secondary outcome
Time at which thumb adductor twitch measurement disappears
Time frame: 1 month after injection
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
Related trials for Physiopathology
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
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.
Guillaume Taylor principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing injection of NMBA in people with Physiopathology, run by Fondation Ophtalmologique Adolphe de Rothschild 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 7 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: stopped early, as of the sponsor's last update on 13 Feb 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Proportion of patients with a score of motion = 0 (time frame: 10 minutes after NMBA or placebo injection). 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 13 Feb 2017.