Comparision of Different Dose of Neostigmine at Advanced Decurarization

NCT00847938 | Completed Phase 3 Results

• 1 other identifier: CHD066-08
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

neostigmine; neuromuscular blocking agent; train of four; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: neostigmine

2

ACTIVE COMPARATOR

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

Drug: neostigmine

3

ACTIVE COMPARATOR

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

Drug: neostigmine

4

NO INTERVENTION

no injection of neostigmine

Interventions

neostigmine DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

MeSH Terms

Interventions

Neostigmine

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Dr Florent CAPRON
• Organization: Clinique Jules Verne

florent.capron@mla.fr

0251171775

Study Officials

• Florent Capron, doctor

  CHD Vendee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 29, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)