The Effect of Periradial Injection of Papaverine Versus N... | NCT04030663

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

NCT04030663

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Sep 16, 2020Actual

Enrollment

90Actual

Phase

Early Phase 1

Conditions

Radial Artery Injury Prevetion

Interventions

papaverine
nitroglycerine
xlyocaine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2019Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 2, 2019Actual

First Submitted Date

Jul 21, 2019

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2020

Last Update Posted Date

Sep 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
papaverine	Active Comparator	Drug: papaverine
nitroglycerine	Active Comparator	Drug: nitroglycerine
xlyocaine	Placebo Comparator	Drug: xlyocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
papaverine	Drug	periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound	papaverine

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Cairo	Benisuef	28735	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010208	Papaverine
D005996	Nitroglycerin

Ancestor Terms

ID	Term
D044182	Benzylisoquinolines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D053610	Opiate Alkaloids

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Browse Branches

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