Observational Study in Bariatric Surgery

NCT ID: NCT04244266

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-29

Study Completion Date

2023-06-14

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Neostigmine Residual Neuromuscular Blockade

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ideal Body Weight

groups of patients divided according to neostigmine dose weight, ideal body weight (IBW)

NO INTERVENTION, it is an observational study

Intervention Type OTHER

No intervention

Total Body Weight

groups of patients divided according to neostigmine dose weight, total body weight (TBW),

NO INTERVENTION, it is an observational study

Intervention Type OTHER

No intervention

Adjusted Body Weight

groups of patients divided according to neostigmine dose weight, , adjusted body weight (ABW)

NO INTERVENTION, it is an observational study

Intervention Type OTHER

No intervention

Interventions

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NO INTERVENTION, it is an observational study

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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2019-A02647-50

Identifier Type: OTHER

Identifier Source: secondary_id

NEOCURE

Identifier Type: -

Identifier Source: org_study_id

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