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

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04030663
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 13.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Injury Prevetion	Drug: papaverine; Drug: nitroglycerine; Drug: xlyocaine	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter Prior to Cannulation.
• Actual Study Start Date: Feb 5, 2019
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Sep 2, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. diameter of radial artery [20 minutes]

   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

Secondary Outcome Measures

1. spasm of radial artery [24 hours]

   detect if there is postoperative spasm of radial artery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Cairo	Benisuef	Egypt	28735

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ahmed said, lecture of anesthesia, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT04030663
• Other Study ID Numbers: FWA00015574
• First Posted: Jul 24, 2019
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nitroglycerin; Papaverine

Study Results

No Results Posted as of Sep 16, 2020