Radial Artery Spasm
Conditions
Keywords
Radial artery spasm, Papaverine, Cerebral angiography
Brief summary
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
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.
Interventions
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%);
DRUGnormal saline
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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients scheduled for cerebral angiography will be eligible for screening. 2. Participant is willing and is able to give informed consent for participating in the trial. 3. Male or Female, aged 18 years or above.
Exclusion criteria
1. Any patient with negative modified Allen test 2. Altered liver function 3. atrioventricular heart block III degree 4. Suspected or confirmed cerebral hemorrhage patients 5. Hemodynamic Instability : systolic pressure \< 100 mmHg, heart rate \> 100 bpm, tachycardia uncontrollable. 6. Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke 7. Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a bridge vessel 8. Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons 9. Hypersensitivity or contraindication to papaverine 10. Hypersensitivity or contraindication to nitroglycerine 11. Glaucomatous patients 12. Parkinson's disease patients 13. Women who are suspected or known to be pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of RAS | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pain intensity of the right forearm | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | 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. |
| The incidence of transradial approach failure | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | Transradial approach failure is defined as needing to change the route to complete the surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The risk of death, non fatal myocardial infarction, and stroke | Within 1 week after surgery | The incidence of death, non fatal myocardial infarction, and stroke |
| Severe systemic hypotension | Within 24 hours after surgery or during surgery | Systolic blood pressure decrease\>30 mmHg or need to use vasopressor medication |
| Complications at the puncture site | Within 24 hours after surgery | The incidence of complications at the puncture site |
Countries
China
Contacts
Primary ContactYamei Tang, PhD
Outcome results
None listed