Articaine vs Dexmedetomidine Supplemented Articaine

November 19, 2019 updated by: simon Halim Armanious, Ain Shams University

Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation Under Ultrasound- Guided Supraclavicular Block

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasya
      • Cairo, Abbasya, Egypt
        • Ain Shams University hosptal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Patients received ultrasound guided supraclavicular block with 40 ml of Articaine hydrochloride 2%
Drug: Articaine
Vial
Experimental: Group AD
Patients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg).
Drug: Articaine
Vial
Drug: Dexmedetomidine
Vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of sensory block
Time Frame: 24 hours
Sensory block time tested by pinprick test measured in minute
24 hours
Duration of motor block
Time Frame: 24 hours
Motor block time tested by Bromage scale measured in minutes
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: 24 hours
Measured by visual analog scale score 4
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation
Time Frame: 24 hours
Measured by Ramsay sedation scale score 3
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Galal Mo Professor, Doctor, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • articaine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participants data for all primary and secondary outcome measures will be available

IPD Sharing Time Frame

Within 6 month after study completion

IPD Sharing Access Criteria

Data access request will be reviewed by external independent reviewers panal. Request will be required to sign data access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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