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Articaine vs Dexmedetomidine Supplemented Articaine

Primary Purpose

Renal Failure

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Articaine
Dexmedetomidine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Hemodialysis

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University hosptal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group AD

Arm Description

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

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

Outcomes

Primary Outcome Measures

Duration of sensory block
Sensory block time tested by pinprick test measured in minute
Duration of motor block
Motor block time tested by Bromage scale measured in minutes

Secondary Outcome Measures

Duration of analgesia
Measured by visual analog scale score 4

Full Information

First Posted
November 15, 2019
Last Updated
November 19, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04171349
Brief Title
Articaine vs Dexmedetomidine Supplemented Articaine
Official Title
Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation Under Ultrasound- Guided Supraclavicular Block
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients received ultrasound guided supraclavicular block with 40 ml of Articaine hydrochloride 2%
Arm Title
Group AD
Arm Type
Experimental
Arm Description
Patients received ultrasound guided supraclavicular block with 40 ml articaine 2% mixed with dexmedetomidine (1 µg/kg).
Intervention Type
Drug
Intervention Name(s)
Articaine
Intervention Description
Vial
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Vial
Primary Outcome Measure Information:
Title
Duration of sensory block
Description
Sensory block time tested by pinprick test measured in minute
Time Frame
24 hours
Title
Duration of motor block
Description
Motor block time tested by Bromage scale measured in minutes
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Duration of analgesia
Description
Measured by visual analog scale score 4
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Sedation
Description
Measured by Ramsay sedation scale score 3
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galal Mo Professor, Doctor
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University hosptal
City
Cairo
State/Province
Abbasya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33487824
Citation
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.
Results Reference
derived

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Articaine vs Dexmedetomidine Supplemented Articaine

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