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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Spasm
• Intervention / Treatment: Drug: Papaverine Hydrochloride; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yamei Tang, PhD; Phone Number: +86-020-34070569; Email: tangym@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Yamet Tang, M. D., Ph. D; Phone Number: 86-020-34070569; Email: yameitang@hotmail.com
      • Principal Investigator: Yamei Tang, M. D., Ph. D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%);	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%);
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Severe systemic hypotension	Systolic blood pressure decrease>30 mmHg or need to use vasopressor medication	Within 24 hours after surgery or during surgery
Complications at the puncture site	The incidence of complications at the puncture site	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Chair: Yamei Tang, PhD, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Papaverine; Radial artery spasm; Cerebral angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Peripheral Vascular Diseases; Spasm; Muscle Cramp; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Papaverine
• Other Study ID Numbers: 20230421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No