NCT04030663

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

July 21, 2019

Last Update Submit

September 13, 2020

Conditions

Radial Artery Injury Prevetion

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • spasm of radial artery

    24 hours

Study Arms (3)

papaverine

ACTIVE COMPARATOR
Drug: papaverine

nitroglycerine

ACTIVE COMPARATOR
Drug: nitroglycerine

xlyocaine

PLACEBO COMPARATOR
Drug: xlyocaine

Interventions

papaverineDRUG

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
nitroglycerineDRUG

periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound

nitroglycerine
xlyocaineDRUG

periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound

xlyocaine

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, Benisuef, 28735, Egypt

Location

MeSH Terms

Interventions

PapaverineNitroglycerin

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitro CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of anesthesia

Study Record Dates

First Submitted

July 21, 2019

First Posted

July 24, 2019

Study Start

February 5, 2019

Primary Completion

September 1, 2019

Study Completion

September 2, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)