Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

Seoul National University Hospital116 enrolled

Overview

The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve the first-attempt success rate of radial artery cannulation. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation in pediatric patients undergoing general anesthesia. Prior to the procedure, each patient will be randomized into either the control arm, saline, or study arm, nitroglycerin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Arterial Line

Interventions

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * General anesthesia * Arterial cannulation for hemodynamic monitoring, multiple blood sample Exclusion Criteria: * Hypersensitivity or contraindication to nitroglycerine * Unstable vital sign, significant arrhythmia or hypotension, Shock * High risk of peripheral ischemia * Skin disease, infection, hematoma, recent cannulation at radial artery. * Increased intracranial pressure, Intracranial hemorrhage * Glaucoma * Recent use of PDE5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)

Outcomes

Primary Outcomes

First attempt success rate

Success at the first skin puncture

Time frame: During radial artery cannulation (up to 1 hour)

Secondary Outcomes

Size of radial artery

Internal diameter of radial artery

Time frame: Before and after subcutaneous injection of drugs (up to 1 hour)

depth of radial artery

depth of radial artery from the skin

Time frame: Before and after subcutaneous injection of drugs (up to 1 hour)

Overall attempt

Number of attempt of radial artery cannulation

Time frame: During radial artery cannulation (up to 1 hour)

Overall Procedure time

From ultrasound guidance, to Arterial waveform

Time frame: During radial artery cannulation (up to 1 hour)

Overall success rate

Success within 4 skin puncture (2 skin puncture at each radial artery)

Time frame: During radial artery cannulation (up to 1 hour)

Malfunction of radial artery catheter

Invasive blood pressure monitoring, Sampling

Time frame: After radial artery cannulation assessed during anesthesia (up to 24 hour)

Complication rate

Hematoma, Distal ischemia, Spasm accessed by ultrasound

Time frame: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)

Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes