NCT04244266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 29, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

3.4 years

First QC Date

January 24, 2020

Last Update Submit

July 4, 2023

Conditions

ObesityNeostigmineResidual Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

Ideal Body Weight

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

Other: NO INTERVENTION, it is an observational study

Total Body Weight

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

Other: NO INTERVENTION, it is an observational study

Adjusted Body Weight

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

Other: NO INTERVENTION, it is an observational study

Interventions

NO INTERVENTION, it is an observational studyOTHER

No intervention

Adjusted Body WeightIdeal Body WeightTotal Body Weight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients whose BMI will be higher than 35 kg/m²

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

ObesityDelayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

January 29, 2020

Primary Completion

June 14, 2023

Study Completion

June 14, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)