search
Back to results

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

Primary Purpose

Radial Artery Spasm

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Papaverine Hydrochloride
normal saline
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radial Artery Spasm focused on measuring Radial artery spasm, Papaverine, Cerebral angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients scheduled for cerebral angiography will be eligible for screening. Participant is willing and is able to give informed consent for participating in the trial. Male or Female, aged 18 years or above. Exclusion Criteria: Any patient with negative modified Allen test Altered liver function atrioventricular heart block III degree Suspected or confirmed cerebral hemorrhage patients Hemodynamic Instability : systolic pressure < 100 mmHg, heart rate > 100 bpm, tachycardia uncontrollable. Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a "bridge vessel" Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons Hypersensitivity or contraindication to papaverine Hypersensitivity or contraindication to nitroglycerine Glaucomatous patients Parkinson's disease patients Women who are suspected or known to be pregnant or breastfeeding

Sites / Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Papaverine

Placebo

Arm Description

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%);

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
The incidence of transradial approach failure
Transradial approach failure is defined as needing to change the route to complete the surgery.

Full Information

First Posted
May 3, 2023
Last Updated
June 8, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT05861765
Brief Title
The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography
Acronym
PASS
Official Title
The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Spasm
Keywords
Radial artery spasm, Papaverine, Cerebral angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Papaverine
Arm Type
Experimental
Arm Description
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%);
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Papaverine Hydrochloride
Intervention Description
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
Intervention Name(s)
normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of RAS
Description
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.
Time Frame
Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Secondary Outcome Measure Information:
Title
The pain intensity of the right forearm
Description
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".
Time Frame
Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Title
The incidence of transradial approach failure
Description
Transradial approach failure is defined as needing to change the route to complete the surgery.
Time Frame
Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Other Pre-specified Outcome Measures:
Title
The risk of death, non fatal myocardial infarction, and stroke
Description
The incidence of death, non fatal myocardial infarction, and stroke
Time Frame
Within 1 week after surgery
Title
Severe systemic hypotension
Description
Systolic blood pressure decrease>30 mmHg or need to use vasopressor medication
Time Frame
Within 24 hours after surgery or during surgery
Title
Complications at the puncture site
Description
The incidence of complications at the puncture site
Time Frame
Within 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients scheduled for cerebral angiography will be eligible for screening. Participant is willing and is able to give informed consent for participating in the trial. Male or Female, aged 18 years or above. Exclusion Criteria: Any patient with negative modified Allen test Altered liver function atrioventricular heart block III degree Suspected or confirmed cerebral hemorrhage patients Hemodynamic Instability : systolic pressure < 100 mmHg, heart rate > 100 bpm, tachycardia uncontrollable. Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a "bridge vessel" Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons Hypersensitivity or contraindication to papaverine Hypersensitivity or contraindication to nitroglycerine Glaucomatous patients Parkinson's disease patients Women who are suspected or known to be pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yamei Tang, PhD
Phone
+86-020-34070569
Email
tangym@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, PhD
Organizational Affiliation
Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamet Tang, M. D., Ph. D
Phone
86-020-34070569
Email
yameitang@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yamei Tang, M. D., Ph. D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs