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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Radial Artery Spasm

Treatments: Drug: normal saline; Drug: Papaverine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05861765

20230421

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Papaverine

Experimental group

Description:

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%);

Treatment:

Drug: Papaverine Hydrochloride

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal saline