The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography

Study Overview
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Brief Summary
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Rationale:Papaverine is effective on radial artery spasm during transradial cerebral angiography. Purpose: This multicenter, randomized, placebo-controlled, double blind, phase 2b trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.

Detailed Description
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Radial artery spasm (RAS) is a common complication during transradial cerebral angiography. RAS can lead to severe pain and remains the most frequent cause of transradial angiography failure. There is currently no consensus on the prevention strategy for RAS. Papaverine has anti vasospasm, sedative and analgesic effects. However, there is no evidence for the efficacy of papaverine in preventing RAS. This multicenter, randomized, double blind, placebo-controlled trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.

Official Title
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The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial

Conditions
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Radial Artery Spasm

Intervention / Treatment
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* Drug: Papaverine Hydrochloride
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients scheduled for cerebral angiography will be eligible for screening. Participant is willing and is able to give informed consent for participating in the trial. Male or Female, aged 18 years or above. Exclusion Criteria: Any patient with negative modified Allen test Altered liver function atrioventricular heart block III degree Suspected or confirmed cerebral hemorrhage patients Hemodynamic Instability : systolic pressure < 100 mmHg, heart rate > 100 bpm, tachycardia uncontrollable. Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a bridge vessel Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons Hypersensitivity or contraindication to papaverine Hypersensitivity or contraindication to nitroglycerine Glaucomatous patients Parkinson's disease patients Women who are suspected or known to be pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Papaverine<br>Slowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%); | Drug: Papaverine Hydrochloride<br>* Slowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%);<br>|
| Placebo Comparator: Placebo<br>After inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, and continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation. | Drug: normal saline<br>* After inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, then continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of RAS | The primary outcome of this trial is to evaluate the incidence of RAS during surgery. The operator assessed RAS on the basis of a questionnaire addressing the following five signs: persistent forearm pain, pain response on catheter manipulation, pain response to introducer withdrawal, difficult catheter manipulation after being trapped by the radial artery with considerable resistance on withdrawal of the introducer. RAS was considered to be indicated by the presence of at least 2 of these 5 signs or by the presence of just 1 when the operator considered it necessary to administer other spasmolytic agent. | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain intensity of the right forearm | Evaluate the pain intensity of the right forearm during the surgery based on the Numerical Rate Scale(NRS), which evaluates the worst pain during the surgery from 0 indicating No Pain to 10 indicating Pain as bad as you can imagine. | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | 
| The incidence of transradial approach failure | Transradial approach failure is defined as needing to change the route to complete the surgery. | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial artery spasm, Papaverine, Cerebral angiography