| CTRI Number |
CTRI/2022/07/044209 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
15/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of subcutanous injection of nitroglycerine on radial artery cannulation |
|
Scientific Title of Study
|
Comparative study of periarterial Infilteration of nitroglycerine with lignocaine vs lignocaine alone in ultrasound guided radial artery cannulation in ICU patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geeta Ahlawat |
| Designation |
Professor |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of Cardiac Anaesthesia ,PGIMS Rohtak
Department of Anaesthesia
Rohtak
HARYANA
124001
India |
| Phone |
9215810279 |
| Fax |
|
| Email |
drgeetasaroha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geeta Ahlawat |
| Designation |
Professor |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of Cardiac Anaesthesia ,PGIMS Rohtak
Department of Anaesthesia
Rohtak
HARYANA
124001
India |
| Phone |
9215810279 |
| Fax |
|
| Email |
drgeetasaroha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geeta Ahlawat |
| Designation |
Professor |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of Cardiac Anaesthesia ,PGIMS Rohtak
Department of Anaesthesia
Rohtak
HARYANA
124001
India |
| Phone |
9215810279 |
| Fax |
|
| Email |
drgeetasaroha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department ofanesthesiology and critical care PGIMS Rohtak.Haryana. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical care Pt BD Sharma PGIMS Rohtak |
| Address |
Pt.BDS PGIMS;Rohtak |
| 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 |
| Aakanksha |
Pt BDS PGIMS ,Rohtak. |
Department of Anaesthesiology and Critical Care
Rohtak
HARYANA |
9518413702
aadviksingh16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutuional ethics committee pt. b.d. sharma pgims rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , , (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lignocaine alone |
subcutanous infilteration of lignocaine NTG Mixture in LN GROUP Will be compared with lignocaine alone in L group |
| Intervention |
Radial artery cannulation |
Subcutanous infiltration of lignocaine-nitroglycerine mixture result in significant increase in radial artery diameter in LN group in comparison to L GROUP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ICU patients in age group 18-65 years who require radial artery cannulation for IBP monitoring and frequent ABG analysis |
|
| ExclusionCriteria |
| Details |
Modified allen test coagulopathy
(INR >1.5), Platelet count <70000,peripheral artery disease ,hand deformity ,inadequate circulation to upper extremity infection over injection site . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare radial artery diameter in lignocaine +Nitroglycerine with lignicaine alone. |
Radial artery diameter 3minutes after subcutanous infilteration of drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare change in radial artery diameter in both group |
3 minutes after subcutanous infilteration of study drug |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
subcutaneous infiltration of lignocaine-NTG mixture in LN group resulted in a significant increase in radial artery diamensions in comparison to lignocaine alone in L GROUP. Consequently ,a significantly higher overall success rate,first attempt success rate observed in NTG group.allso insertion time and number of attempts were significantly lower in Lignocaine group |