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.
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexmedetomidine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Dexmedetomidine
CAS Number: 145108-58-3
Other descriptive name: DEXMEDE
Sponsors
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: *Healthy male volunteers aged between 18 and 45 years. *BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Duration of sensory block of the ulnar nerve ;Secondary Objective: Onset time of sensory block of the ulnar nerve 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Duration of sensory and motor blockade *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. | — |
Countries
Austria
Contacts
Public ContactMaya Keplinger
Medizinische Universität Wien
Outcome results
None listed