ObesityNEOCURENCT04244266
Observational Study in Bariatric Surgery
An observational study of Obesity and Neostigmine, run by Poitiers University Hospital at 1 site in France.
Trial summary
Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Neostigmine, Residual Neuromuscular Blockade
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2020to 14 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients whose BMI will be higher than 35 kg/m²
Who may be able to join
- Adult obese patients (≥ 18 years and BMI ≥ 35 Kg/m²), both sexes
- Any elective bariatric surgery
- Neuromuscular blockade with rocuronium
- Maintenance of anesthesia with a halogenated agent
- Free patient, without guardianship or subordination
- Patients with a social security coverage
- No opposition given by the patient after clear and fair information
Who cannot join
- Patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine,
- Emergency surgery,
- Severe renal and / or hepatic insufficiency,
- Persons benefiting from enhanced protection, namely pregnant women, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally sick people in emergency situation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery
Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.
According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.
Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.
- Conditions
- Obesity, Neostigmine, Residual Neuromuscular Blockade
- Being tested
- NO INTERVENTION, it is an observational study
- Medical subject headings
- Obesity, Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTION, it is an observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Ideal Body Weight | groups of patients divided according to neostigmine dose weight, ideal body weight (IBW) Receives: Other: NO INTERVENTION, it is an observational study | |
| Total Body Weight | groups of patients divided according to neostigmine dose weight, total body weight (TBW), Receives: Other: NO INTERVENTION, it is an observational study | |
| Adjusted Body Weight | groups of patients divided according to neostigmine dose weight, , adjusted body weight (ABW) Receives: Other: NO INTERVENTION, it is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mean delay to recovery of neuromuscular blockade after pharmacological reversal according to the dosage of neostigmine administered to the patient (on TBW, IBW or ABW
Delay between the injection of neostigmine T0 and obtain a ratio between the 4th and the 1st response (T4/T1) by "Four-Train Stimulator" (TOF) ≥ 0.9
Measured: Few minutes after injection of neostigmine
Secondary outcomes (1)
Compare the frequence of side effects according to the dosage of neostigmine administered (on TBW, IBW or ABW)
Occurrence of bradycardia defined by a heart rate <50 beats per minute in the hour following the injection of neostigmine Occurrence of bronchospasm defined by a desaturation over 92% and sibilants to the auscultation within one hour after neostigmine injection.
Measured: Within one hour after the injection of neostigmine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start29 Jan 2020
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 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
- NCT04244266
- Sponsor's protocol ID
- NEOCURE
- Other IDs
- 2019-A02647-50
- Acronym
- NEOCURE
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2020
- Last updated
- 6 Jul 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04244266
- Acronym / sponsor ID
- NEOCURE / NEOCURE
- Conditions
- Obesity, Neostigmine, Residual Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 28 Jan 2020 (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.
Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.
According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.
Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ideal Body Weight | – | Other: NO INTERVENTION, it is an observational studygroups of patients divided according to neostigmine dose weight, ideal body weight (IBW) |
| Total Body Weight | – | Other: NO INTERVENTION, it is an observational studygroups of patients divided according to neostigmine dose weight, total body weight (TBW), |
| Adjusted Body Weight | – | Other: NO INTERVENTION, it is an observational studygroups of patients divided according to neostigmine dose weight, , adjusted body weight (ABW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients whose BMI will be higher than 35 kg/m²
Key inclusion criteria (7 listed)
- Adult obese patients (≥ 18 years and BMI ≥ 35 Kg/m²), both sexes
- Any elective bariatric surgery
- Neuromuscular blockade with rocuronium
- Maintenance of anesthesia with a halogenated agent
- Free patient, without guardianship or subordination
Key exclusion criteria (4 listed)
- Patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine,
- Emergency surgery,
- Severe renal and / or hepatic insufficiency,
- Persons benefiting from enhanced protection, namely pregnant women, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally sick people in emergency situation.
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 |
|---|---|---|
| NO INTERVENTION, it is an observational studyNo intervention | Other | Adjusted Body Weight, Ideal Body Weight, Total Body Weight |
Primary outcome
Compare the mean delay to recovery of neuromuscular blockade after pharmacological reversal according to the dosage of neostigmine administered to the patient (on TBW, IBW or ABW
Time frame: Few minutes after injection of neostigmine
Delay between the injection of neostigmine T0 and obtain a ratio between the 4th and the 1st response (T4/T1) by "Four-Train Stimulator" (TOF) ≥ 0.9
1 secondary outcome
Compare the frequence of side effects according to the dosage of neostigmine administered (on TBW, IBW or ABW)
Time frame: Within one hour after the injection of neostigmine
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 6 Jul 2023.
- 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.
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?
An observational study of Obesity and Neostigmine, 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 7 inclusion and 4 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 6 Jul 2023. 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?
Compare the mean delay to recovery of neuromuscular blockade after pharmacological reversal according to the dosage of neostigmine administered to the patient (on TBW, IBW or ABW (time frame: Few minutes after injection of neostigmine). 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 6 Jul 2023.