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CTRI Number  CTRI/2025/05/087575 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 25/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of nitroglycerine injection for easy access of radial artery for monitoring in patients undergoing heart surgery  
Scientific Title of Study   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  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanika Chanauria 
Designation  Major (Dr) 
Affiliation  Army Hospital Research and Referral 
Address  Department of Anesthesiology and Critical Care, Army Hospital Research and Referral, Subroto Park, Delhi Cantt, New Delhi

South West
DELHI
110010
India 
Phone  8826206100  
Fax    
Email  kcdrkacy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  G S Ghotra 
Designation  Colonel (Dr) 
Affiliation  Army Hospital Research and Referral 
Address  Department of Cardiac Anesthesia, Army Hospital Research and Referral, Subroto Park, Delhi Cantt, New Delhi

South West
DELHI
110010
India 
Phone  7261955514  
Fax    
Email  gpsghotra5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  G S Ghotra 
Designation  Colonel (Dr) 
Affiliation  Army Hospital Research and Referral 
Address  Department of Cardiac Anesthesia, Army Hospital Research and Referral, Subroto Park, Delhi Cantt, New Delhi

South West
DELHI
110010
India 
Phone  7261955514  
Fax    
Email  gpsghotra5@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  G S Ghotra 
Address  Department of Cardiac Anesthesia, Army Hospital Research and Referral, Subroto Park, Delhi Cantt, New Delhi 
Type of Sponsor  Other [Army Hospital Research and Referral ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kanika Chanauria  Army Hospital Research and Referral  Department of Anesthesiology and Critical Care, Army Hospital Research and Referral, Subroto Park, Delhi Cantt, New Delhi
South West
DELHI 
8826206100

kcdrkacy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Army Hospital R and R Delhi Cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patients will receive subcutaneous infiltration of 1 mL normal saline + 2 ml of 2% lignocaine (placebo) at the radial artery site before cannulation. 
Intervention  Subcutaneous Nitroglycerin (NL)  Patients will receive subcutaneous nitroglycerin infiltration (dose: 500 mcg diluted in 1 mL normal saline + 2ml of 2% lignocaine) at the radial artery site before cannulation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  (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.
 
 
ExclusionCriteria 
Details  (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

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
(a) Change in radial artery diameter (mm) before and after NTG + lignocaine or Saline + lignocaine (measured via ultrasound)  at baseline, after one minute 
 
Secondary Outcome  
Outcome  TimePoints 
(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:
a. Number of attempts required for successful cannulation
b. Time needed for successful access of radial artery
(d) Pre-cannulation radial artery spasm:
a. Subjective assessment by the operator (graded as absent, mild, moderate, or severe)
 
at baseline, after one minute of injection  
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kcdrkacy@gmail.com].

  6. For how long will this data be available start date provided 15-05-2025 and end date provided 15-05-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary  

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.

 

 
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