Dexmedetomidine in IVRA

Study Overview
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Brief Summary
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A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,

Detailed Description
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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.

Official Title
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Comparison of Two Different Doses of Dexmedetomidine Added to Lignocaine in Patients Posted for Upper Limb Orthopedic Surgery Under Intravenous Regional Anaesthesia

Conditions
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Regional Anesthesia Morbidity

Intervention / Treatment
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* Drug: Dexmedetomidine Injectable Solution [Dexdomitor]
* Drug: Lidocaine IV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) alone diluted with normal saline 0.9% to make the final volume 30 ml | Drug: Lidocaine IV<br>* Intravenous regional anaesthesia<br>|
| Active Comparator: Group II<br>Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.25 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml. | Drug: Dexmedetomidine Injectable Solution [Dexdomitor]<br>* 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<br>Drug: Lidocaine IV<br>* Intravenous regional anaesthesia<br>|
| Active Comparator: Group III<br>Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.5 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml | Drug: Dexmedetomidine Injectable Solution [Dexdomitor]<br>* 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<br>Drug: Lidocaine IV<br>* Intravenous regional anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hollmen scale | change from base line for the scale (scale from 1 to 4) | 2 hours | 
| modified bromage scale | change from baseline for the scale (scale from 0 to 4 ) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue score | changes in the scale from 0 to 10 | 2 hours | 
| ramsey sedation score | changes in the scale from 1 to 4 | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Lignocaine, Upper Limb Orthopedic Surgery, Intravenous Regional Anaesthesia