The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter

The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter Prior to Cannulation.

Compare the effect of periradial injection of papaverine versus nitroglycerine on radial artery diamter before cannulation of it in cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Radial Artery Injury Prevetion
• Intervention / Treatment: Drug: papaverine; Drug: nitroglycerine; Drug: xlyocaine

Detailed Description

we want in this study to facilitate radial artery canulation and decrease the number of attemps of puncture which may lead to disappearance of the pulse.

The aim of this study is to compare the effect of adding papaverine to local anesthetic xylocaine versus adding nitroglycerine to it on the diameter and palpability of radial artery and if perioperative spasm will decrease significantly with one of these methods.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Benisuef
    • Cairo, Benisuef, Egypt, 28735
      • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Patients who will be included in the study are those scheduled for elective cardiac surgery who are hemodynamically stable.

Exclusion Criteria:

• Any patient with negative modified Allen test, atrioventricular block, glaucoma, altered liver function, unstable hemodynamics, emergency surgeries, and peripheral vascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: papaverine	Drug: papaverine; periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
Active Comparator: nitroglycerine	Drug: nitroglycerine; periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
Placebo Comparator: xlyocaine	Drug: xlyocaine; periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diameter of radial artery	after periradial injection of one of the drugs we will feel the radial artery pulse and record if there is a change in the palpatory score and mesure the diameter of the radial artery by ultrasound in cardiac surgery patients	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spasm of radial artery	detect if there is postoperative spasm of radial artery	24 hours

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 2, 2019

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Nitroglycerin; Papaverine
• Other Study ID Numbers: FWA00015574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No