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Clinical Trials/NCT06424145
NCT06424145Enrolling By InvitationNot Applicable

A Single-center, Randomized and Controlled Clinical Research Projects

Ting Xu1 site in 1 country216 target enrollmentStarted: June 30, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
216
Locations
1
Primary Endpoint
Success ratio of first radial artery puncture

Study Overview

Brief Summary

Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.

Detailed Description

Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ASA Class I-III, patients aged 18-80 years
  • •Planned surgery with radial artery catheterization
  • •Allen test negative
  • •Sign the informed consent form and voluntarily participate in this trial

Exclusion Criteria

  • •Inflamed skin at puncture site
  • •Extremely nervous and unable to cooperate
  • •Ultrasonographic assessment of aberrant radial artery
  • •Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
  • •The patient had undergone radial artery catheterization in the same arm in the past week
  • •History of hypersensitivity to local anesthetics

Arms & Interventions

Superior group of radial artery

Experimental

Injection of 1% lidocaine 1 ml above the artery

Intervention: Superior radial artery (Diagnostic Test)

Right radial artery group

Experimental

Injection of 1% lidocaine 1 ml to the right side of the artery

Intervention: Right side of radial artery (Diagnostic Test)

Outcomes

Primary Outcomes

Success ratio of first radial artery puncture

Time Frame: Day 1

What is the probability of success the first time?

Secondary Outcomes

  • Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes(Day 1)

Investigators

Sponsor
Ting Xu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ting Xu

Chief physician

Sichuan Provincial People's Hospital

Study Sites (1)

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