Articaine vs Dexmedetomidine Supplemented Articaine

NCT ID: NCT04171349

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-11-01

Brief Summary

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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

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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)

Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

Patients received ultrasound guided supraclavicular block with 40 ml of Articaine hydrochloride 2%

Group Type ACTIVE_COMPARATOR

Articaine

Intervention Type DRUG

Vial

Group AD

Patients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg).

Group Type EXPERIMENTAL

Articaine

Intervention Type DRUG

Vial

Dexmedetomidine

Intervention Type DRUG

Vial

Interventions

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Articaine

Vial

Intervention Type DRUG

Dexmedetomidine

Vial

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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simon Halim Armanious

Simon Halim, MD S. Armanious

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Galal Mo Professor, Doctor

Role: STUDY_DIRECTOR

Professor

Locations

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Ain Shams University hosptal

Cairo, Abbasya, Egypt

Site Status

Countries

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Egypt

References

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Armanious SH, Abdelhameed GA. Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation under Ultrasound-guided Supraclavicular Block. Anesth Essays Res. 2020 Apr-Jun;14(2):248-252. doi: 10.4103/aer.AER_147_19. Epub 2020 Oct 12.

Reference Type DERIVED
PMID: 33487824 (View on PubMed)

Other Identifiers

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Articaine

Identifier Type: -

Identifier Source: org_study_id

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