Articaine vs Dexmedetomidine Supplemented Articaine

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04171349
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 9.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Drug: Articaine; Drug: Dexmedetomidine	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation Under Ultrasound- Guided Supraclavicular Block
• Actual Study Start Date: Jun 1, 2019
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of sensory block [24 hours]

   Sensory block time tested by pinprick test measured in minute

2. Duration of motor block [24 hours]

   Motor block time tested by Bromage scale measured in minutes

Secondary Outcome Measures

1. Duration of analgesia [24 hours]

   Measured by visual analog scale score 4

Other Outcome Measures

1. Sedation [24 hours]

   Measured by Ramsay sedation scale score 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hosptal	Cairo	Abbasya	Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Galal Mo Professor, Doctor, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: simon Halim Armanious, Simon Halim, MD S. Armanious, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04171349
• Other Study ID Numbers: Articaine
• First Posted: Nov 20, 2019
• Last Update Posted: Nov 20, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by simon Halim Armanious, Simon Halim, MD S. Armanious, Ain Shams University: Hemodialysis
• Additional relevant MeSH terms: Renal Insufficiency; Dexmedetomidine; Carticaine

Study Results

No Results Posted as of Nov 20, 2019