| CTRI Number |
CTRI/2025/06/088589 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"THE EFFICACY OF NITROGLYCERIN LINGUAL SPRAY DIFFERENT DOSES 400MCG AND 800MCG IV LIGNOCAINE IN ATTENUATION OF
PRESSOR RESPONSE FOLLOWING INTUBATION:A RANDOMISED CONTROLLED TRIAL" |
|
Scientific Title of Study
|
"THE EFFICACY OF NITROGLYCERIN LINGUAL SPRAY 400MCG AND 800MCG IV LIGNOCAINE IN
ATTENUATION OF PRESSOR RESPONSE FOLLOWING
INTUBATION: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 |
Dr Priyank V |
| Designation |
Assistant professor |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE Bengaluru |
| Address |
Assistant professor
Anaesthesiology Department
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
BANGALORE
Anaesthesiology Department
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE Bengaluru
K R fort Rd
560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9986539562 |
| Fax |
|
| Email |
priyabmc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Priyank V |
| Designation |
Assistant professor |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE Bengaluru |
| Address |
Assistant professor
Anaesthesiology Department
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
BANGALORE
Anaesthesiology Department
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE Bengaluru
K R fort Rd
560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9986539562 |
| Fax |
|
| Email |
priyabmc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyank V |
| Designation |
Assistant professor |
| Affiliation |
BMCRI Bengaluru |
| Address |
Assistant professor
Anaesthesiology Department
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
BANGALORE
Anaesthesiology Department
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE Bengaluru
K R fort Rd
560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9986539562 |
| Fax |
|
| Email |
priyabmc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| VICTORIA HOSPITAL
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
|
|
Primary Sponsor
|
| Name |
SOMANATH R GOLAGI |
| Address |
Door No 72
Halasangi Chadachan
Vijaypura 586207 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrPriyanka V |
Assistant Professor Anaesthesiology Department
BMCRI |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSomanath R Golagi |
VICTORIA Hospital |
3rd floor
Anaesthesiology Department century Building Bengaluru
KR fort Rd
560002
Bangalore
KARNATAKA |
7760241096
somanathrg96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Bangalore Medical College and Research institute , Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj - Lignocaine 2% iv 3 cc before doing scopy only once given IV |
Reduction in PRESSOR RESPONSE FOLLOWING INTUBATION |
| Intervention |
NITROGLYCERIN 400mcg lingual spray given Only once before 1 min doing laryngoscopy |
comparing the different dose of nitroglycerin dosage 800 MCG and Requirement of nitroglycerin dose for reduction of pressor response |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group of patients comes under American society of Anaesthesia 1 and 2 undergoing surgery under General anaesthesia |
|
| ExclusionCriteria |
| Details |
Obstetrics patients
Childrens
Allergic to drug any type of Allegies
Any patient refusal |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of PRESSOR RESPONSE FOLLOWING INTUBATION using lingual spray of drug |
Prevention of PRESSOR RESPONSE FOLLOWING INTUBATION within minutes 1 min 2 min 5 min 10 min 15 min 20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nil Reduction in the pressure response following intubation
Might require higher doses a |
1 minutes
3 minutes
5 minutes
10 Minutes
15 Minutes |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
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
|
The Nitroglycerin a potent hypotensive agent when it is used iv . Laryngoscopy is essential to do intratracheal intubation to secure definitive Airway in patient undergoing Surgery under General anaesthesia. The inevitable pressure response. Following intubation Haemodyanmic changes so to minimise these response ,risks and possible complications the lingual spray useful in preventing the pressure response of the Laryngoscopy .The study calculate optimum dosage with comparison with other drug like lignocaine iv for reducing response . |