EUCTR2013-002078-30-BE
Active, Not Recruiting
N/A
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 sitesJuly 11, 2013
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Onze-Lieve-Vrouw Ziekenhuis
- Status
- Active, Not Recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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