NEOCURE: Observational Study in Bariatric Surgery
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ideal Body Weight groups of patients divided according to neostigmine dose weight, ideal body weight (IBW) |
Other: NO INTERVENTION, it is an observational study
No intervention
|
| Total Body Weight groups of patients divided according to neostigmine dose weight, total body weight (TBW), |
Other: NO INTERVENTION, it is an observational study
No intervention
|
| Adjusted Body Weight groups of patients divided according to neostigmine dose weight, , adjusted body weight (ABW) |
Other: NO INTERVENTION, it is an observational study
No intervention
|
Outcome Measures
Primary Outcome Measures
- 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 [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
Secondary Outcome Measures
- Compare the frequence of side effects according to the dosage of neostigmine administered (on TBW, IBW or ABW) [Within one hour after the injection of neostigmine]
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.
Eligibility Criteria
Criteria
Inclusion Criteria*:
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Adult obese patients (≥ 18 years and BMI ≥ 35 Kg/m²), both sexes
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Any elective bariatric surgery
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Neuromuscular blockade with rocuronium
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Maintenance of anesthesia with a halogenated agent
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Free patient, without guardianship or subordination
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Patients with a social security coverage
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No opposition given by the patient after clear and fair information
Exclusion Criteria*:
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Patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine,
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Emergency surgery,
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Severe renal and / or hepatic insufficiency,
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Poitiers | Poitiers | France | 86000 |
Sponsors and Collaborators
- Poitiers University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEOCURE
- 2019-A02647-50