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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2023-10-30

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.

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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.

Conditions

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Radial Artery Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Papaverine

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%);

Group Type EXPERIMENTAL

Papaverine Hydrochloride

Intervention Type 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%);

Placebo

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type 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.

Interventions

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Papaverine Hydrochloride

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%);

Intervention Type DRUG

normal 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No