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Completed

NCT Number: NCT05123170

Dexmedetomidine in IVRA

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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine Injectable Solution [Dexdomitor]

Drug

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

Lidocaine IV

Drug

Intravenous regional anaesthesia

Primary outcomes

  1. hollmen scale

    Time frame: 2 hours

    change from base line for the scale (scale from 1 to 4)

  2. modified bromage scale

    Time frame: 2 hours

    change from baseline for the scale (scale from 0 to 4 )

Secondary outcomes

  1. visual analogue score

    Time frame: 2 hours

    changes in the scale from 0 to 10

  2. ramsey sedation score

    Time frame: 2 hours

    changes in the scale from 1 to 4

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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