Observational Study in Bariatric Surgery

Completed

• Conditions: Obesity; Residual Neuromuscular Blockade; Neostigmine
• Interventions: Other: NO INTERVENTION, it is an observational study

• Registration Number: NCT04244266
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Study Start: 2020-01-29
• Primary Completion: 2023-06-14
• Study Completion: 2023-06-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ideal Body Weight	NO INTERVENTION, it is an observational study	groups of patients divided according to neostigmine dose weight, ideal body weight (IBW)
Total Body Weight	NO INTERVENTION, it is an observational study	groups of patients divided according to neostigmine dose weight, total body weight (TBW),
Adjusted Body Weight	NO INTERVENTION, it is an observational study	groups of patients divided according to neostigmine dose weight, , adjusted body weight (ABW)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France