Regional Anesthesia Morbidity
Conditions
Keywords
Dexmedetomidine, Lignocaine, Upper Limb Orthopedic Surgery, Intravenous Regional Anaesthesia
Brief summary
A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,
Detailed description
After obtaining approval of the medical and ethical committee of Menoufia University & Nasser Institute for Research and Treatment, an informed and written consent from the patients, a prospective controlled randomized double blinded study will be performed Sample size: MedCalc® version 12.3.0.0 program Ostend, Belgium was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 80% with α error 5%, According to a previous study (13), showed that the duration of tourniquet time in group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value \>0.05, while Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is success in the group B compared to group A, but there is no difference. So it can be relied upon in this study, based on this assumption, sample size was calculated according to these values produced a minimal samples size of 86 cases were enough to find such a difference. Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three groups 30 cases in each group. Patients will be randomly categorized into three equal groups (30 patients each): The patients will be randomly allocated to one of these three groups, using a computer-generated sequence of random numbers and a sealed envelope technique.
Interventions
DRUGDexmedetomidine Injectable Solution [Dexdomitor]
two different doses of dexemedetomidine (0.25 μg /kg and 0.5 μg/kg) as adjunct to lignocaine in intravenous regional anesthesia for upper limb orthopedic surgeries
DRUGLidocaine IV
Intravenous regional anaesthesia
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients of ASA class I and II. * Patients of either sex. * Patients aged between 20-70 years. * Patients scheduled for forearm and hand surgery lasting for about 60 minutes.
Exclusion criteria
* Patient with known hypersensitivity to any study medications. * Patient with Severe peripheral vascular disease and neurological disease. * Where use of tourniquet will be either not possible or contraindicated. * Patient with Hemolytic diathesis specially sickle cell anemia, epilepsy, diabetes mellitus, hypertension, cardiovascular disease like myocardial infarction, cardiac arrhythmias, heart block and altered mentation. * Procedures lasting for more than 90 min will be also not considered. * Therapy with adrenergic receptor antagonist, calcium channel blocker and ACE inhibitors. * Patient with impaired liver function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hollmen scale | 2 hours | change from base line for the scale (scale from 1 to 4) |
| modified bromage scale | 2 hours | change from baseline for the scale (scale from 0 to 4 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue score | 2 hours | changes in the scale from 0 to 10 |
| ramsey sedation score | 2 hours | changes in the scale from 1 to 4 |
Countries
Egypt
Outcome results
None listed