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

Radial Artery Spasm Clinical Trial

— PASS  

Official title:

The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861765
• Other study ID #: 20230421
• Status: Recruiting
• Phase: Phase 2
• Start date: May 24, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yamei Tang, PhD
• Phone: +86-020-34070569
• Email: tangym[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Cramp
• Peripheral Vascular Diseases
• Radial Artery Spasm
• Spasm

Intervention

Drug:
• 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%);
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The risk of death, non fatal myocardial infarction, and stroke	The incidence of death, non fatal myocardial infarction, and stroke	Within 1 week after surgery
Other	Severe systemic hypotension	Systolic blood pressure decrease>30 mmHg or need to use vasopressor medication	Within 24 hours after surgery or during surgery
Other	Complications at the puncture site	The incidence of complications at the puncture site	Within 24 hours after surgery
Primary	The incidence of RAS	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.	Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Secondary	The pain intensity of the right forearm	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".	Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Secondary	The incidence of transradial approach failure	Transradial approach failure is defined as needing to change the route to complete the surgery.	Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.