DEXMEDETOMIDINE FOR PERIPHERAL NERVE BLOCKADE: A DOSE-FINDING STUDY IN VOLUNTEERS - Dose Finding Study for Dex

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie0 个研究点开始时间: 2013年9月24日最近更新: 2014年2月17日

适应症

试验速览

暂无简介。

•*Healthy male volunteers aged between 18 and 45 years.
•*BMI < 30 kg/m2
•*Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug
•*No legal incapacity and/or other circumstances rendering the volunteer unable to
•understand the nature, scope and possible consequences of the study
•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 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•*Anatomical abnormalities of the forearm identified by physical examination *Use of NSAID during the last 2 weeks
•*Known allergy or hypersensitivity to ropivacaine or other amino-amide LA
•*Known allergy or hypersensitivity to dexmedetomidine
•*Participation in another clinical study within the last 4 weeks prior to study *Coagulopathy
•*Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and
•hypertension with a systolic BP > 160 mmHg) after 5 min resting
•*Bradycardia with a heart rate after 5 min resting of < 40 b/min
•*Abnormalities in ECG that are considered clinically relevant like AV-block or
•bradycardia
•*Unreliability and/or lack of cooperation *Other objections to participate in the study in the opinion of the investigator

发起方

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie