Dexmedetomidine in IVRA

NCT05123170 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2/2020ANET11
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regional Anesthesia Morbidity

Keywords

Dexmedetomidine; Lignocaine; Upper Limb Orthopedic Surgery; Intravenous Regional Anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• visual analogue score

  2 hours

• ramsey sedation score

  2 hours

Study Arms (3)

Group I

ACTIVE COMPARATOR

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

Group II

ACTIVE COMPARATOR

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]; Drug: Lidocaine IV

Group III

ACTIVE COMPARATOR

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]; Drug: Lidocaine IV

Interventions

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

Group II; Group III

Lidocaine IV DRUG

Intravenous regional anaesthesia

Group I; Group II; Group III

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sadek AM Sadek, MD

  Menoufia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 17, 2021
• Study Start: February 28, 2020
• Primary Completion: March 25, 2021
• Study Completion: June 20, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)