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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Papaverine | Experimental | 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%); |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papaverine Hydrochloride | Drug | 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%); |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The risk of death, non fatal myocardial infarction, and stroke | The incidence of death, non fatal myocardial infarction, and stroke | Within 1 week after surgery |
| Severe systemic hypotension | Systolic blood pressure decrease>30 mmHg or need to use vasopressor medication |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yamei Tang, PhD | Contact | +86-020-34070569 | tangym@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yamei Tang, PhD | Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40930776 | Derived | Pan D, Yang J, Liu M, Xu Y, Feng J, Li H, Luo W, He B, Xiao S, Yang X, Tang Y. Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography (PASS): rationale and design. Stroke Vasc Neurol. 2026 Apr 27;11(2):261-266. doi: 10.1136/svn-2024-003659. |
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| ID | Term |
|---|---|
| D010208 | Papaverine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D053610 | Opiate Alkaloids |
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|
| normal saline | Drug | 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. |
|
| 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. |
| Within 24 hours after surgery or during surgery |
| Complications at the puncture site | The incidence of complications at the puncture site | Within 24 hours after surgery |
| D007546 |
| Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |