Acceleromyography and diaphragm electromyographic activity during neostigmine or sugammadex enhanced recovery from moderate residual neuromuscular blockade after rocuronium 0.6 mg kg-1: a double blind randomized study in anaesthetized healthy volunteers - REcovery of Diaphragmatic function after NEuromuscular blockade and the role of Sugammadex (REDNES)

Onze-Lieve-Vrouw Ziekenhuis0 个研究点开始时间: 2013年7月11日最近更新: 2013年11月4日

试验速览

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•A subject is only eligible and may enter the study, if all of the following criteria are met:
•1.Only male, healthy volunteers will be enrolled after an in-depth interview
•2.Each participant must have the mental capacity to decide whether he takes part in the trial or not. Each participant must voluntarily give his written informed consent.
•3.Each participant must be between 18 and 35 (inclusive) years of age at the screening visit
•4.Each participant must meet the American Society of Anaesthesiologists class I criteria.
•5.Subject has a Body Mass Index (BMI) = 26 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Volunteers may not have participated in a drug study within 90 days prior to dosing. A subject is ineligible and may not enter the study, if any of the following conditions are observed:
•1.Known or suspected to have a neuromuscular disorder.
•2.Use of medications known to interfere with NMBAs.
•3.Known or suspected allergic reaction to sugammadex, neostigmine, rocuronium, anaesthetic or narcotic medications, or any drugs used during general anaesthesia.
•4.Known or suspected to have an anatomical malformation impeding a proper intubation.
•5.Family or personal history of problems related to anaesthesia.
•6.Known or suspected to have a history of malignant hyperthermia.
•7.Known to have a renal insufficiency.
•8.Current smoker or history of smoking.
•9.Drinking more than 2 consumptions of alcohol a day.
•10.Known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher.
•11.Known to have an infection of the upper or lower airways, as diagnosed by clinical findings.
•12.Reflux oesophagitis.

发起方

Onze-Lieve-Vrouw Ziekenhuis