| CTRI Number |
CTRI/2025/04/083861 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| 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
|
to mnow the change of size in radial artery after NTG Lignocaine infilteration in pateints under anesthesia posted for surgery |
|
Scientific Title of Study
|
ultrasound evaluation of radial artery size and ease of cannulation post subcutaneous infiltration of nitroglycerine and lignocaine versus lignocaine in prospective comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHRADDHA DEVENDRA DEVRUKHKAR |
| Designation |
ADDITIONAL ASSOCIATE PROFFESOR |
| Affiliation |
seth gsmc and kem hospital mumbai |
| Address |
kem hospital , anaesthesia department , old building first floor
Mumbai (Suburban)
MAHARASHTRA
400066
India |
| Phone |
8879333788 |
| Fax |
|
| Email |
shraddhadevrukhkar@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
dr pravin annarao waghmare |
| Designation |
junior resident |
| Affiliation |
seth gsmc and kem hospital mumbai |
| Address |
Department of Anaesthesia
Division Old building
Room No 139
Parel
Districrt Mumbai
Department of Anaesthesia
Division Old building
Room No 139
Parel
Districrt Mumbai
Mumbai
MAHARASHTRA
400066
India |
| Phone |
7758065485 |
| Fax |
|
| Email |
pravinwaghmare144@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRADDHA DEVENDRA DEVRUKHKAR |
| Designation |
ADDITIONAL ASSOCIATE PROFFESOR |
| Affiliation |
seth gsmc and kem hospital mumbai |
| Address |
Department of Anaesthesia
Division Old building
Room No 139
Parel
Districrt Mumbai
Department of Anaesthesia
Division Old building
Room No 139
Parel
Districrt Mumbai
Mumbai
MAHARASHTRA
400066
India |
| Phone |
8879333788 |
| Fax |
|
| Email |
shraddhadevrukhkar@kem.edu |
|
|
Source of Monetary or Material Support
|
| PI AND CO-I
Dept of Anaesthesia, kem hospital anaesthesia department , old building
parel 400012 |
|
|
Primary Sponsor
|
| Name |
dr pravin waghmare |
| Address |
139 Dept of Anaesthesia
KEM Hospital Parel 400012 |
| Type of Sponsor |
Government medical college |
|
|
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 shraddha devrukhkar |
seth gsmc and kem hospital mumbai |
Dept of Anaesthesia
139 room no
KEM Hospital parel 400012
parel Mumbai 400012
Mumbai
MAHARASHTRA |
8879333788
shraddhadevrukhkar@kem.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comitee iec 3 seth gsmc and kem hospital mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj lignocaine 2% 1ml |
study drug will be infilterated by usg around radial artery once
duration of intervention- upto 1 minute
change of size will be noted. |
| Intervention |
INJ Nitroglycerine 0.2 ml and inj lignocaine 0.8 ml
|
total inj lignocaine and inj nitroglycerine will be infiltrated locally around radial artery site..once
duratin of intervention - upto 1min
after 1 minute reading of radial artery size will be taken. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing all kind of elective surgery under GA requiring radial arterial line |
|
| ExclusionCriteria |
| Details |
1 Patients who refused to give consent
2 ASA grade 3 and 4
3 Positive modified Allens test
4 Peripheral arterial disease
5Infection burn at the site of insertion
6 Coagulopathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in size of artery post drug infilteration |
change in size of artery post drug infilteration at 0 minutes at 3 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration needed for securing radial line |
time in minutes |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
29/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/04/2025 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
patient will be randomly allocated to one of the group by closed envelope technique . group L - INJ LIGNOCAINE 2% 1 ML group N - inj 0.2 ml NTG + inj lignocaine 2% 0.8 ml usg will be done by anaesthetist who has done minimum 30 radial artey usg . 3 readings of each parameters will be taken and mean will be calculated. |