Articaine vs Dexmedetomidine Supplemented Articaine

Early Phase 1

Completed

• Conditions: Renal Failure
• Interventions: Drug: Articaine; Drug: Dexmedetomidine

• Registration Number: NCT04171349
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory, motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided supraclavicular block

Detailed Description

Adult fifty patient with chronic renal failure on hemodialysis, scheduled for arteriovenous fistula creation under ultrasound guided supraclavicular block. Patients were randomly allocated in two group. The articaine group (group A) received 40 ml articaine hydrochloride 2% and articaine-dexmedetomidine group (group AD) received 40 ml. Of articaine 2% mixed with dexmedetomidine (1micogram/kg)

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-10-01
• Status Verified: 2019-11
• Study Completion: 2019-11-01
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• adult patient with chronic renal failure on hemodialysis scheduled for radiocephalic fistula creation

Exclusion Criteria

• Allergy to local anesthetics.
• Infection at the site of needle insertion.
• Those having international normalized ratio more than 1.5.
• Coagulopathy.
• Neuromuscular, or severe hepatic or severe pulmonary disease.
• Those having epilepsy.
• Patients who refused to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Articaine	Patients received ultrasound guided supraclavicular block with 40 ml of Articaine hydrochloride 2%
Group AD	Articaine	Patients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg).
Group AD	Dexmedetomidine	Patients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg).

Primary Outcome Measures

Name	Time	Method
Duration of sensory block	24 hours	Sensory block time tested by pinprick test measured in minute
Duration of motor block	24 hours	Motor block time tested by Bromage scale measured in minutes

Secondary Outcome Measures

Name	Time	Method
Duration of analgesia	24 hours	Measured by visual analog scale score 4

Trial Locations

Locations (1)

Ain Shams University hosptal; 🇪🇬 Cairo, Abbasya, Egypt