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

Phase 2
Recruiting
Conditions
Radial Artery Spasm
Interventions
Registration Number
NCT05861765
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
240
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.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PapaverinePapaverine HydrochlorideSlowly 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%);
Placebonormal salineAfter 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.
Primary Outcome Measures
NameTimeMethod
The incidence of RASIntraprocedural: 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 Outcome Measures
NameTimeMethod
The pain intensity of the right forearmIntraprocedural: 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 failureIntraprocedural: 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.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

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