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CTRI Number  CTRI/2021/11/037704 [Registered on: 01/11/2021] Trial Registered Prospectively
Last Modified On: 02/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of an experimental drug in two different dose combination versus control drug alone for insertion of radial artery cannula using ultrasound 
Scientific Title of Study   Effect of combination of subcutaneous lignocaine with two different doses of nitroglycerin versus subcutaneous lignocaine alone for ultrasound guided radial artery cannulation: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saras Singh 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Science Patna 
Address  Dept. of Anaesthesiology, All India Institute of Medical Science Patna
Phulwari Sharif Patna
Patna
BIHAR
801507
India 
Phone  9788859989  
Fax    
Email  drssarassingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajnish Kumar 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science Patna 
Address  Dept. of Anaesthesiology All India Institute of Medical Science Patna
Phulwari Sharif Patna
Patna
BIHAR
801507
India 
Phone  9788859989  
Fax    
Email  drraj76pmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saras Singh 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Science Patna 
Address  Dept. of Anaesthesiology, All India Institute of Medical Science Patna
Phulwari Sharif Patna
Patna
BIHAR
801507
India 
Phone  9788859989  
Fax    
Email  drssarassingh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Patna 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical Sciences Patna, Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 
Type of Sponsor  Research institution and hospital 
 
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 
Saras Singh  All India Institute Of Medical Sciences Patna   Dept. of Anaesthesiology
Patna
BIHAR 		 9788859989

drssarassingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection of subcutaneous lignocaine with subcutaneous Nitroglycerin 500 microgram  Injection of subcutaneous lignocaine 1% with subcutaneous Nitroglycerin 500 microgram in 0.5 ml (total) over the radial artery 
Intervention  Injection of subcutaneous lignocaine with subcutaneous Nitroglycerin 250 microgram  Injection of subcutaneous lignocaine 1% with subcutaneous Nitroglycerin 250 microgram in 0.5 ml (total) over the radial artery 
Comparator Agent  Subcutaneous lignocaine  Injection of subcutaneous lignocaine 1% 0.5 ml over the radial artery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All adult patients admitted in Intensive Care Unit (ICU) or undergoing elective surgeries in Operating room at AIIMS Patna requiring radial artery cannulation. 
 
ExclusionCriteria 
Details  Infection overlying the site, Absent pulse/poor circulation assessed by the modified Allen’s test, Coagulopathy, Partial/full thickness burn, Vascular graft in upper extremity, any vascular disease. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate the first-attempt success rate of radial artery cannulation.  5 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the overall success rate of radial artery cannulation.  5 minutes 
To compare the diameter & cross sectional area of radial artery before and after subcutaneous administration of drugs.  5 minutes 
To compare the mean number of attempts of radial artery cannulation.
 		 5 minutes 
To estimate the percentage of patients developing puncture site hematoma.  5 minutes 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) 31/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 Arterial cannulation is widely used in operating rooms, intensive care units, and emergency departments. Radial artery is the most common site of cannulation. Radial artery cannulation often requires multiple attempts, which are painful. We require methods that can increase first-pass success rate. Drugs like nitroglycerin cause significant vasodilation that may assist arterial cannulation and lignocaine is commonly used for analgesia. Combination of both these may improve success rates of painless radial artery cannulation significantly. 

Not many studies have assessed effect of different doses of nitroglycerin for ultrasound guided radial artery cannulation in adults when combined with lignocaine.

 Adding vasodilators like nitroglycerin to lignocaine may significantly increase first-attempt success rates. Comparable first pass success rates may be obtained with lower doses of nitroglycerin. Significant increase in the diameter & cross sectional area of radial artery after subcutaneous administration of nitroglycerin.

 
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