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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04171349
Other study ID # Articaine
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 1, 2019
Est. completion date November 1, 2019

Study information

Verified date November 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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)


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Articaine
Vial
Dexmedetomidine
Vial

Locations

Country Name City State
Egypt Ain Shams University hosptal Cairo Abbasya

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Sedation Measured by Ramsay sedation scale score 3 24 hours
Primary Duration of sensory block Sensory block time tested by pinprick test measured in minute 24 hours
Primary Duration of motor block Motor block time tested by Bromage scale measured in minutes 24 hours
Secondary Duration of analgesia Measured by visual analog scale score 4 24 hours
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