Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation

June 17, 2023 updated by: Mahidol University
The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Anesthesiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18-75 years
  • the patient who need to arterial line

Exclusion Criteria:

  • allergy to nicardipine
  • history of peripheral artery disease
  • BMI > 40 kg/m2
  • unwilling to participate or denial of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicardipine
Using nicardipine 0.5 mg(0.5ml) subcutaneously infiltrated by ultrasound before redial artery cannulation.
Drug: Nicardipine
Subcutaneous infiltrate drug at puncture site by ultrasound-guided
Placebo Comparator: Normal saline
Using normal saline 0.5ml subcutaneously infiltrated by ultrasound before redial artery cannulation
Other: Normal saline
Subcutaneous infiltrate NSS at puncture site by ultrasound-guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of radial artery cannulation since first skin puncture
Time Frame: 10 minute from puncture at skin
Success rate of radial artery cannulation since first skin puncture
10 minute from puncture at skin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radial artery diameter
Time Frame: Pre-induction to 3 minute after subcutaneous infiltration
Pre-induction radial artery diameter, post-induction radial artery diameter, radial artery diameter after subcutaneous infiltration at 0,1,2 and 3 minute
Pre-induction to 3 minute after subcutaneous infiltration
Time from first skin puncture to success cannulation
Time Frame: 10 minutes
Time from first skin puncture to present of arterial wave form, assessed less than 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Phuriphon Songarj, MD, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 17, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 764/2565(IRB3)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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