Observational Study in Bariatric Surgery (NEOCURE)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Neostigmine; Residual Neuromuscular Blockade
• Intervention / Treatment: Other: NO INTERVENTION, it is an observational study

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • CHU De Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients whose BMI will be higher than 35 kg/m²

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: NEOCURE; 2019-A02647-50 (Other Identifier: IDB-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO