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

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

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity
• Intervention / Treatment: Drug: Lidocaine IV; Drug: Dexmedetomidine Injectable Solution [Dexdomitor]

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32511
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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: Lidocaine IV; Intravenous regional anaesthesia; 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
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: Lidocaine IV; Intravenous regional anaesthesia; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Sadek AM Sadek, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Lignocaine; Upper Limb Orthopedic Surgery; Intravenous Regional Anaesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: 2/2020ANET11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes