Comparision of Different Dose of Neostigmine at Advanced Decurarization

Anesthesia Clinical Trial

— NEODEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847938
• Other study ID #: CHD066-08
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• neostigmine
0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
• neostigmine
0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
• neostigmine
0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %

Locations

Country	Name	City	State
France	CHD Vendée	La Roche Sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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