| CTRI Number |
CTRI/2024/06/069435 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of lignocaine given as nebulization with intravenous lignocaine for decreasing of stress response to laryngoscopy and intubation in patients posted for elective general anaesthesia. |
|
Scientific Title of Study
|
A comparative study of lignocaine nebulization with intravenous lignocaine for attenuation of pressor response to laryngoscopy and intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hublikar Hemanth |
| Designation |
Postgraduate student |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
First floor, New stone building, Department of Anaesthesiology,Mysore Medical College and Research Institute, Irwin road, next to
railway station, Mysuru, Karnataka
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9731543812 |
| Fax |
|
| Email |
hemanth96.hublikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudarshan M B |
| Designation |
Associate professor. |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
First floor, News Stone building, Department of Anaesthesiology, Mysore medical college and Research Institute, Irwin road, next to
railway station, Mysuru, Karnataka
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9900262710 |
| Fax |
|
| Email |
drmbs1975@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudarshan M B |
| Designation |
Associate professor. |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
First floor, New stone building, Department of Anaesthesiology, Mysore medical college and Research Institute, Irwin road, next to
railway station, Mysuru, Karnataka
Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9900262710 |
| Fax |
|
| Email |
drmbs1975@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical college and research Institute, Irwin road, Mysore, Karnataka, India- 570001. |
|
|
Primary Sponsor
|
| Name |
Hublikar Hemanth |
| Address |
Mysore medical college and Research Institute, Irwin road, next to
railway station, mysore, 570001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Hublikar Hemanth |
Mysore medical college |
Operation Theatre, Department of
Anaesthesiology, first
floor, New stone building, KR
hospital
Mysore.
Mysore
KARNATAKA |
9731543812
hemanth96.hublikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Mysore medical college and research Institute and associated hospitals. |
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 |
Comparison between nebulized lignocaine and Intravenous lignocaine in attenuation of intubation response. |
Comparing effects of nebulized lignocaine(2mg/kg) and intravenous lignocaine(2mg/kg) given once prior to intubation in attenuation of stress response in patients undergoing General anesthesia posted for elective surgeries . Patient is observed for a period of about 15 minutes post intubation. |
| Intervention |
Two Different routes(Nebulization and intravenous) of Lignocaine 2% is used prior to laryngoscopy and intubation |
Lignocaine 2% 2mg/kg dose is used in two different routes intravenous and nebulization once prior to laryngoscopy and intubation to know its effects for about 15 minutes post intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA 1 and 2 patients between 18-65 years posted for elective surgeries under general anesthesia. |
|
| ExclusionCriteria |
| Details |
1) ASA grade 3 and 4.
2) Diabetic and Hypertensive patients.
3) known history of drug allergy.
4) Pregnant and lactating women.
5) Chronic respiratory and cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the effects of intravenous lignocaine IV 2% (2mg/kg) with nebulization of 2% lignocaine (2 mg/kg) on hemodynamic response to laryngoscopy and endotracheal intubation. |
From shifting on OT table till 15 minutes post endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate any side effects with use of this drug in both routes |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a prospective randomised controlled study to compare the effects of Nebulization Of lignocaine 2% with Intravenous lignocaine 2% in attenuation of response to laryngoscopy and endotracheal intubation. Sample size is 100. Patients posted for elective surgeries under General anaesthesia are randomly divided into two groups, 50 receiving Nebulization of lignocaine and 50 receiving Intravenous lignocaine prior to intubation . Hemodynamic response are recorded in those patients and effects are compared. |