Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

Not Applicable

Completed

• Conditions: Arterial Line
• Interventions: Drug: Normal saline; Drug: Nitroglycerin

• Registration Number: NCT03849183
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-03-20
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation.
Nitroglycerin	Nitroglycerin	Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.

Primary Outcome Measures

Name	Time	Method
First attempt success rate	During radial artery cannulation (up to 1 hour)	Success at the first skin puncture

Secondary Outcome Measures

Name	Time	Method
Overall Procedure time	During radial artery cannulation (up to 1 hour)	From ultrasound guidance, to Arterial waveform
Overall success rate	During radial artery cannulation (up to 1 hour)	Success within 4 skin puncture (2 skin puncture at each radial artery)
Size of radial artery	Before and after subcutaneous injection of drugs (up to 1 hour)	Internal diameter of radial artery
Overall attempt	During radial artery cannulation (up to 1 hour)	Number of attempt of radial artery cannulation
depth of radial artery	Before and after subcutaneous injection of drugs (up to 1 hour)	depth of radial artery from the skin
Malfunction of radial artery catheter	After radial artery cannulation assessed during anesthesia (up to 24 hour)	Invasive blood pressure monitoring, Sampling
Complication rate	After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)	Hematoma, Distal ischemia, Spasm accessed by ultrasound

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of