Dexmedetomidine in IVRA

Menoufia University

Status and phase: Completed; Phase 4

Conditions: Regional Anesthesia Morbidity

Treatments: Drug: Dexmedetomidine Injectable Solution [Dexdomitor]; Drug: Lidocaine IV

Study type: Interventional

Funder types: Other

Identifiers

NCT05123170

2/2020ANET11

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups

Group I

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine IV

Group II

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine IV

Drug: Dexmedetomidine Injectable Solution [Dexdomitor]

Group III

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine IV

Drug: Dexmedetomidine Injectable Solution [Dexdomitor]