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

Centre Hospitalier Departemental Vendee

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT00847938

CHD066-08

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 4 patient groups

1

Active Comparator group

Description:

neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg

Treatment:

Drug: neostigmine

Drug: neostigmine

Drug: neostigmine

2

Active Comparator group

Description:

neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg

Treatment:

Drug: neostigmine

Drug: neostigmine

Drug: neostigmine

3

Active Comparator group

Description:

neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg

Treatment:

Drug: neostigmine

Drug: neostigmine

Drug: neostigmine

4

No Intervention group

Description:

no injection of neostigmine