| CTRI Number |
CTRI/2026/01/100926 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of how local nitroglycerin affects placing a radial artery cannula in newborn babies |
|
Scientific Title of Study
|
Local Nitroglycerin For Radial Artery Cannulation In Neonates- A Randomised 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 |
Harshitha G |
| Designation |
Senior resident |
| Affiliation |
Postgraduate Institute Of Medical Education and Research (PGIMER) |
| Address |
House no-35 , second Floor, sector 15A, Chandigarh
2/1, Harshollasa Nilaya, balaji nagara, Devannanpalya, Dasanpura, Nelamangala, Bangalore -562123
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9731963673 |
| Fax |
|
| Email |
harshithamanu2601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute Of Medical Education and Research(PGIMER) |
| Address |
6th floor , A block, OT complex, Advanced Pediatric Centre, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8288860604 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute Of Medical Education and Research(PGIMER) |
| Address |
6th floor , A block, OT complex, Advanced Pediatric Centre, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8288860604 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Pediatric Anaesthesia, Department of Anaesthesia and Intensive Care Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
PGIMER, Madya Marg, sector 12, Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Harshitha G |
Postgraduate Institute of Medical Education and Research(PGIMER) |
Division of Pediatric Anaesthesia, Department of Anaesthesia and Intensive Care ,Postgraduate Institute Of Medical Education and Research Centre
Chandigarh
CHANDIGARH |
9731963673
harshithamanu2601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline is injected subcutaneously prior to radial artery cannulation |
Normal saline at a dose of 0.1 ml/kg will be administered only once over 10 seconds into the subcutaneous plane under ultrasound guidance. |
| Intervention |
Subcutaneous injection of Nitroglycerin before radial artery cannulation |
Nitroglycerin 5mcg/kg diluted to a total concentration of 0.1 ml/kg will be given only once over 10 seconds in the subcutaneous plane under ultrasound guidance.” |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate of radial artery cannulation |
At the first attempt of radial artery cannulation, at the completion of radial artery cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diameter of radial aretry |
Before injecting the test drug, 3 minutes after injecting the test drug and Post cannulation |
| Number of attempts to cannulate radial artery |
After successful cannulation of radial artery |
| Overall procedure time |
After successful cannulation of radial artery |
| Incidence of Vasospasm |
After cannulation of radial artery |
| Incidence of hematoma |
After cannulation of radial artery |
| Incidence of Hypotension |
Baseline and thereafter every two minutes and upto 20 minutes after injection of the study drug |
|
|
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 4 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
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. |