Dexmedetomidine in IVRA
Study Details
Study Description
Brief Summary
A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I 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
Intravenous regional anaesthesia
|
| Active Comparator: Group II 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]
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
Drug: Lidocaine IV
Intravenous regional anaesthesia
|
| Active Comparator: Group III 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]
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
Drug: Lidocaine IV
Intravenous regional anaesthesia
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Menoufia University | Shibīn Al Kawm | Menoufia | Egypt | 32511 |
Sponsors and Collaborators
- Menoufia University
Investigators
- Study Chair: Sadek AM Sadek, MD, Menoufia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2/2020ANET11