Clinical trial NCT05861765: The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography
Official title: The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radial Artery Spasm
Keywords: Radial artery spasm
Papaverine
Cerebral angiography
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of RAS
timeFrame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Secondary outcomes:
measure: The pain intensity of the right forearm
timeFrame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
measure: The incidence of transradial approach failure
timeFrame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Other outcomes:
measure: The risk of death, non fatal myocardial infarction, and stroke
timeFrame: Within 1 week after surgery
measure: Severe systemic hypotension
timeFrame: Within 24 hours after surgery or during surgery
measure: Complications at the puncture site
timeFrame: Within 24 hours after surgery
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
name: Yamei Tang, PhD
role: STUDY_CHAIR
References: