Articaine vs Dexmedetomidine Supplemented Articaine

NCT04171349 | Completed Early Phase 1

• 1 other identifier: Articaine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Failure

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Duration of sensory block

  Sensory block time tested by pinprick test measured in minute

  24 hours

• Duration of motor block

  Motor block time tested by Bromage scale measured in minutes

  24 hours

Secondary Outcomes (1)

• Duration of analgesia

  24 hours

Other Outcomes (1)

• Sedation

  24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Articaine

Group AD

EXPERIMENTAL

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

Drug: Articaine; Drug: Dexmedetomidine

Interventions

Articaine DRUG

Vial

Group A; Group AD

Dexmedetomidine DRUG

Vial

Group AD

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hosptal

Cairo, Abbasya, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33487824 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Carticaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Galal Mo Professor, Doctor

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simon Halim, MD S. Armanious

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 20, 2019
• Study Start: June 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 6 month after study completion
• Access Criteria: Data access request will be reviewed by external independent reviewers panal. Request will be required to sign data access

Locations

EG (1)