Comparision of Different Dose of Neostigmine at Advanced Decurarization (NEODEC)

Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: neostigmine; Drug: neostigmine; Drug: neostigmine

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • La Roche Sur Yon, France, 85925
    • CHD Vendée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient > 18 years
• informed consent signed
• Patient undergoing any type of scheduled surgery under general anesthesia for which curarization with eventually a maintenance is indicated
• ASA score between I to III

Exclusion Criteria:

• patient > 75 years and < 18 years
• body mass index > 32 mg/m²
• neurology disease, neuromuscular or muscular disease
• peripheral neuropathy
• coronary heart disease
• asthma
• familial history of malign hyperthermia
• difficulty of intubation and ventilation
• full stomach
• known or suspected allergy to one of the study drug
• mecanique obstruction of digestive or urinary tract
• open-angle glaucoma
• patient with risk of urinary retention linked to urethra-prostatic disorder
• concomittant medication with a influence known on neuromuscular (aminosid, anti-convulsif and corticosteroid
• child bearing women or nursing mother
• no affiliation at a social security

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg	Drug: neostigmine; 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; Drug: neostigmine; 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; Drug: neostigmine; 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
Active Comparator: 2; neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg	Drug: neostigmine; 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; Drug: neostigmine; 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; Drug: neostigmine; 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
Active Comparator: 3; neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg	Drug: neostigmine; 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; Drug: neostigmine; 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; Drug: neostigmine; 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
No Intervention: 4; no injection of neostigmine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesure of the Train-of-four (TOF)	train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation.	from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Florent Capron, doctor, CHD Vendée

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: anesthesia; neuromuscular blocking agent; train of four; neostigmine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: CHD066-08

Plan for Individual participant data (IPD)

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