Dexmedetomidine (=Drug for Block Prolongation) used for Regionla Anaesthetic Blockade: A Dosefinding Study in Volunteers

Active, not recruiting

Conditions: 24 Volunteers recieve an ultrasound guided ulnar nerve block, and apparted into 4 groups. Group 1 receives 3ml Ropivacaine 0.75% without adjuvants. Group 2-4 receives 3ml Ropivacain 0.75% with three different doses of dexmedetomidine (50, 100,150 mcg). The aim of the study is to eveluate the optimal dose regarding sensory duration of nerve block without side effects of dexmedetomidine.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-003790-10-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

*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

Exclusion Criteria

*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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Duration of sensory block of the ulnar nerve ;Secondary Objective: Onset time of sensory block of the ulnar nerve <br>Onset time and duration of motor blockade Vigilance status;Primary end point(s): Demedetomidine ad an adjuvant prolongs the peripheral nerve blockade;Timepoint(s) of evaluation of this end point: Prior to Block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min, 60 min, after the block and then every 30 min until complete recovery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of sensory and motor blockade<br>Optimal dose with maximum prolongation without side effects ;Timepoint(s) of evaluation of this end point: Prior to Block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min, 60 min, after the block and then every 30 min until complete recovery.