The Effect of Subcutaneous Nitroglycerin on the Success Rate of Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Normal saline
- Conditions
- Arterial Line
- Sponsor
- Seoul National University Hospital
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- First attempt success rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital
Eligibility Criteria
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
- •Recent use of PDE5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)
Arms & Interventions
Control
Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation.
Intervention: Normal saline
Nitroglycerin
Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.
Intervention: Nitroglycerin
Outcomes
Primary Outcomes
First attempt success rate
Time Frame: During radial artery cannulation (up to 1 hour)
Success at the first skin puncture
Secondary Outcomes
- Overall success rate(During radial artery cannulation (up to 1 hour))
- Overall Procedure time(During radial artery cannulation (up to 1 hour))
- Size of radial artery(Before and after subcutaneous injection of drugs (up to 1 hour))
- Overall attempt(During radial artery cannulation (up to 1 hour))
- depth of radial artery(Before and after subcutaneous injection of drugs (up to 1 hour))
- Malfunction of radial artery catheter(After radial artery cannulation assessed during anesthesia (up to 24 hour))
- Complication rate(After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour))