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临床试验/CTRI/2025/05/087575
CTRI/2025/05/087575尚未招募2 期

Effects of Subcutaneously Infiltrated Nitroglycerin on Diameter, Palpability, Ease-of-Puncture, and Pre-Cannulation Spasm of the Radial Artery in Patients Undergoing Cardiac Surgery post radial angiography: A Randomized Controlled Trial

G S Ghotra1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
(a)Change in radial artery diameter (mm) before and after NTG + lignocaine or Saline + lignocaine (measured via ultrasound)

研究概览

简要总结

Radial artery cannulation is a critical procedure in cardiac surgery, providing vascular access for monitoring and intervention. However, this procedure is often complicated by factors such as small arterial diameter, reduced palpability, vasospasm, and difficulty in puncture, particularly in patients with a history of recent radial angiography where the radial artery is already punctured which may lead to vasospasm and endothelial dysfunction followed by complications like arterial remodeling altering the anatomy of the radial artery. These challenges can increase procedural failure rates, prolong operative time, and lead to patient discomfort. Effective pre-cannulation strategies are necessary to optimize arterial access and improve procedural success.

Nitroglycerin**, a well-known nitric oxide donor and potent vasodilator, has been widely used in cardiovascular medicine for its ability to relax vascular smooth muscle. Lignocaine(control) is a local anesthetic used commonly, which acts by inhibiting action potential by blocking sodium channel. Both the drugs are standard of care.** When administered subcutaneously, nitroglycerin may increase radial artery diameter, enhance arterial palpability, and reduce pre-cannulation spasm, potentially facilitating easier and more successful cannulation. Through a randomized controlled trial (RCT), we seek to determine whether this pharmacological approach can improve radial artery accessibility and procedural outcomes in this specific patient population.

The findings of this research could provide valuable insights into optimizing radial artery cannulation techniques, potentially leading to enhanced procedural efficiency, reduced complications, and improved patient outcomes in cardiac surgery.

 Novelty of the study - Unlike prior studies focusing on diagnostic or interventional coronary procedures, this study specifically evaluates patients undergoing cardiac surgery who have had prior radial angiography, a group at higher risk of arterial narrowing or spasm thereby hindering the radial artery cannulation, which is the knowledge gap addressed by this study since no previous research has been done in this particular cohort of patients. While intra-arterial and topical nitroglycerin have been studied for similar purposes, the effects of subcutaneous nitroglycerin infiltration specifically in cardiac patients undergoing surgery at least seven days post-radial angiography also remain, underexplored.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • (a)Patients aged 18–75 years scheduled for cardiac surgery.
  • (b)Patients who underwent radial angiography at least 7 days prior.
  • (c)Radial artery deemed suitable for cannulation on pre-procedural ultrasound.
  • (d)Hemodynamically stable patients.

排除标准

  • (a)Radial artery occlusion or severe calcification detected on ultrasound (b)Allergy or contraindication to nitroglycerin (c)Severe hypotension (SBP less than 90 mmHg) or hemodynamic instability (d)Use of vasodilators within the past 6 hours (e)Bleeding disorders or local skin infections at the infiltration site.

结局指标

主要结局

(a)Change in radial artery diameter (mm) before and after NTG + lignocaine or Saline + lignocaine (measured via ultrasound)

时间窗: at baseline, after one minute

次要结局

  • (b)Palpability of the artery (Scored on a 5-point palpation scale: 1= non-palpable, 2= feeble, 3 = palpability same after infiltration, 4= palpability became better after infiltration, 5= pulse became bounding after infiltration)((c)Ease-of-puncture:)

研究者

发起方
G S Ghotra
申办方类型
Other [Army Hospital Research and Referral ]

研究点 (1)

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