| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kcdrkacy@gmail.com].
- 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.
- 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. |