Observational Study 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.

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Key information

Conditions

Obesity Body Weight Delayed Emergence from Anesthesia Neostigmine Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Residual Neuromuscular Blockade Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NO INTERVENTION, it is an observational study

Other

No intervention

Primary outcomes

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

Secondary outcomes

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

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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery

Acronym: NEOCURE

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jan 28, 2020
Registry last updated: Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed