NCT05920538

Brief Summary

The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

May 23, 2023

Last Update Submit

June 17, 2023

Conditions

Radial Artery Cannulation

Keywords

Nicardipineradial arteryartery cannulationultrasound

Outcome Measures

Primary Outcomes (1)

  • Success rate of radial artery cannulation since first skin puncture

    Success rate of radial artery cannulation since first skin puncture

    10 minute from puncture at skin

Secondary Outcomes (2)

  • radial artery diameter

    Pre-induction to 3 minute after subcutaneous infiltration

  • Time from first skin puncture to success cannulation

    10 minutes

Study Arms (2)

Nicardipine

EXPERIMENTAL

Using nicardipine 0.5 mg(0.5ml) subcutaneously infiltrated by ultrasound before redial artery cannulation.

Drug: Nicardipine

Normal saline

PLACEBO COMPARATOR

Using normal saline 0.5ml subcutaneously infiltrated by ultrasound before redial artery cannulation

Other: Normal saline

Interventions

NicardipineDRUG

Subcutaneous infiltrate drug at puncture site by ultrasound-guided

Nicardipine
Normal salineOTHER

Subcutaneous infiltrate NSS at puncture site by ultrasound-guided

Normal saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department

Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

NicardipineSaline Solution

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Phuriphon Songarj, MD

    Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 27, 2023

Study Start

March 13, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations

TH(1)