Observational Study in Bariatric Surgery

Obesity Clinical Trial

— NEOCURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244266
• Other study ID #: NEOCURE
• Secondary ID: 2019-A02647-50
• Status: Completed
• Start date: January 29, 2020
• Est. completion date: June 14, 2023

Study information

• Verified date: July 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neostigmine
• Obesity
• Residual Neuromuscular Blockade

Intervention

Other:
• NO INTERVENTION, it is an observational study
No intervention

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Few minutes after injection of neostigmine
Secondary	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.	Within one hour after the injection of neostigmine