A Phase 2 interventional study of Papaverine Hydrochloride and normal saline in Radial Artery Spasm, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2, Interventional, and Prevention
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.
123 studies on the registry are indexed under Spasm; 7 are open to participants now.
This study's planned enrollment of 240 is above the median of 80 across 104 interventional studies indexed under Spasm.
Browse Spasm studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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%);
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 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.
Time frame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
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".
Time frame: 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.
Time frame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
The risk of death, non fatal myocardial infarction, and stroke
The incidence of death, non fatal myocardial infarction, and stroke
Time frame: Within 1 week after surgery
Severe systemic hypotension
Systolic blood pressure decrease\>30 mmHg or need to use vasopressor medication
Time frame: Within 24 hours after surgery or during surgery
Complications at the puncture site
The incidence of complications at the puncture site
Time frame: Within 24 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Sep 2023, 4 months after the start.
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Papaverine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →