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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05861765

Collaborator

(none)

240

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Spasm	Drug: Papaverine Hydrochloride Drug: normal saline	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

The incidence of RAS [Intraprocedural: 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

The pain intensity of the right forearm [Intraprocedural: 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 failure [Intraprocedural: 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.

Other Outcome Measures

The risk of death, non fatal myocardial infarction, and stroke [Within 1 week after surgery]
The incidence of death, non fatal myocardial infarction, and stroke
Severe systemic hypotension [Within 24 hours after surgery or during surgery]
Systolic blood pressure decrease>30 mmHg or need to use vasopressor medication
Complications at the puncture site [Within 24 hours after surgery]
The incidence of complications at the puncture site

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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