Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Mesure of the Train-of-four (TOF)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patient > 75 years and < 18 years
- •body mass index > 32 mg/m²
- •neurology disease, neuromuscular or muscular disease
- •peripheral neuropathy
- •coronary heart disease
- •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
研究组 & 干预措施
1
neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg
干预措施: neostigmine (Drug)
2
neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg
干预措施: neostigmine (Drug)
3
neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg
干预措施: neostigmine (Drug)
结局指标
主要结局
Mesure of the Train-of-four (TOF)
时间窗: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour
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.
次要结局
未报告次要终点