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临床试验/CTRI/2026/01/100926
CTRI/2026/01/100926尚未招募4 期

Local Nitroglycerin For Radial Artery Cannulation In Neonates- A Randomised Controlled Trial

Postgraduate Institute of Medical Education and Research (PGIMER)1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
94
试验地点
1

研究概览

简要总结

Radial artery cannulation in neonates is technically challenging due to small vessel diameter and a high incidence of arterial spasm, leading to multiple attempts and complications. Nitroglycerin is a potent vasodilator that has shown to  increase radial artery diameter and reduce arterial spasm in adults and older children. Limited data exist regarding its use in neonates, particularly via subcutaneous route. This prospective, randomized controlled trial aims to evaluate the efficacy and safety of subcutaneous nitroglycerin in improving the first-attempt success rate of ultrasound-guided radial artery cannulation in neonates.

Ninety-four neonates undergoing surgery under general anaesthesia will be randomized to receive either subcutaneous nitroglycerin (5mcg/kg) or normal saline over the radial artery under ultrasound guidance prior to cannulation. Cannulation will be performed using dynamic needle tip positioning technique.

Primary outcome is first-attempt success rate. Secondary outcome include total number of attempts, procedure time, changes in radial artery diameter and depth, and incidence of local or systemic complications such as vasospasm, hematoma and hypotension

This study aims to establish a safe and effective strategy to improve arterial cannulation success in neonates and reduce procedure related complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates with postconceptual age greater than 34 weeks and weight greater than 2 kg and those scheduled for major elective or emergency surgery under general anaesthesia.

排除标准

  • neonates with congenital heart disease, any know hypersensitivity or contraindication to Nitroglycerin, wound infection or hematomas at the site of cannulation, known coagulation abnormality, suspected hydrocephalus or raised intracranial pressure, neonates with syndromic facies, known connective tissue disorder and refusal of consent.

研究者

发起方
Postgraduate Institute of Medical Education and Research (PGIMER)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Harshitha G

Postgraduate Institute Of Medical Education and Research (PGIMER)

研究点 (1)

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