NCT05123170

Dexmedetomidine in IVRA

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Regional Anesthesia Morbidity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-28
• Primary completion: 2021-03-25
• Completion: 2021-06-20
• First posted: 2021-11-17
• Last updated: 2022-01-18

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study