Comparision of Different Dose of Neostigmine at Advanced Decurarization

NCT ID: NCT00847938

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-11-30

Brief Summary

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

neostigmine

Intervention Type: DRUG

0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

2

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

Group Type: ACTIVE_COMPARATOR

neostigmine

Intervention Type: DRUG

0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

3

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

Group Type: ACTIVE_COMPARATOR

neostigmine

Intervention Type: DRUG

0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

4

no injection of neostigmine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

neostigmine

0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

Intervention Type: DRUG

neostigmine

0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

Intervention Type: DRUG

neostigmine

0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florent Capron, doctor

Role: PRINCIPAL_INVESTIGATOR

CHD Vendee

Locations

CHD Vendée

La Roche-sur-Yon, , France

Countries

France

Other Identifiers

CHD066-08

Identifier Type: -

Identifier Source: org_study_id