| CTRI Number |
CTRI/2025/11/097907 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of 2% 1mg/kg iv lignocaine versus 2% 2mg/kg nebulized lignocaine for hemodynamic response during scopy |
|
Scientific Title of Study
|
A comparative study of 2 percentage 1mg/kg iv lignocaine versus 2 percentage 2mg/kg nebulized lignocaine for hemodynamic response during laryngoscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRaghunandan Ramawtar Sharma |
| Designation |
First Year Resident |
| Affiliation |
Gujarat Adani institute of medical scieneces, bhuj |
| Address |
Department of Anaesthesiology, g.k.General hospital Gujarat Adani Institute of Medical scieneces, Bhuj. Department of Anaesthesiology G.k. General hospital Bhuj. Kachchh 370001
Department of Anaesthesiology, g.k.General hospital Gujarat Adani Institute of Medical scieneces, Bhuj. Department of Anaesthesiology G.k. General hospital Bhuj. Kachchh 370001
Kachchh
GUJARAT
395010
India |
| Phone |
8128821157 |
| Fax |
|
| Email |
raghusharma563@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandakinee Thacker |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Gujarat Adani institute of medical scieneces |
| Address |
Department of Anaesthesiology, g.k.General hospital Gujarat Adani Institute of Medical scieneces, Bhuj. Department of Anaesthesiology G.k. General hospital Bhuj. Kachchh 370001
Kachchh
GUJARAT
370001
India |
| Phone |
9925007046 |
| Fax |
|
| Email |
mandakinee.thacker@gamis.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandakinee Thacker |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Gujarat Adani institute of medical scieneces |
| Address |
Department of Anaesthesiology, g.k.General hospital Gujarat Adani Institute of Medical scieneces, Bhuj. Department of Anaesthesiology G.k. General hospital Bhuj. Kachchh 370001
Kachchh
GUJARAT
370001
India |
| Phone |
9925007046 |
| Fax |
|
| Email |
mandakinee.thacker@gamis.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gujarat Adani institute of medical scieneces |
| Address |
Department of Anaesthesiology, g.k.General hospital Gujarat Adani Institute of Medical scieneces, Bhuj. Department of Anaesthesiology G.k. General hospital Bhuj. Kachchh 370001 |
| Type of Sponsor |
Private 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 Raghunandan Ramawtar Sharma |
G.k. General hospital Bhuj |
Gujarat Adani institute of medical scieneces Bhuj,
Department of Anaesthesiology 2nd floor main operation theater
Kachchh
GUJARAT |
8128821157
raghusharma563@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
| Intervention |
2 percent lignocaine iv and nebulized |
2 percent 1mg/kg iv lignocaine and 2 percent 2mg/kg nebulized lignocaine |
| Intervention |
Iv lignocaine and neb lignocaine |
2%1mg/kg iv lignocaine |
| Comparator Agent |
Neb lignocaine |
2% 2mg/kg nebulized lignocaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients between aged 18-60 years having ASA grade 1 and 2 posted for elective surgery under general anaesthesia.
Mallampati grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Respiratory or cardiac dysfunction
Renal or liver impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response to laryngoscopy |
0min, 1min,3min,5min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Department of Anaesthesiology, g.k.General hospital Gujarat Adani Institute of Medical scieneces, Bhuj. Department of Anaesthesiology G.k. General hospital Bhuj. To compare the heart rate between the dose of 2% 1ml/kg interavenousand 2% 2mg/kg nebulized lignocaine. To compare blood pressure between the dose of 2% 1ml/kg interavenousand 2% 2mg/kg nebulized lignocaine. To record Adverse drug reaction if any |