| CTRI Number |
CTRI/2026/01/101524 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of efficacy of Lidocaine vs Magnesium sulfate nebulization on intubation response in patients undergoing general anaesthesia with oro-endotracheal intubation. |
|
Scientific Title of Study
|
Comparative study of the efficacy of Lidocaine vs Magnesium sulphate nebulization on attenuation of intubation response in patients undergoing general anaesthesia |
| 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. R NANDHINI |
| Designation |
Postgraduate Resident |
| Affiliation |
Jss Medical College and Hospital, Mysore, Karnataka |
| Address |
Department of Anaesthesiology,
Jss Medical College and Hospital,
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9489761919 |
| Fax |
|
| Email |
nandhini_51@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. BP MANJULA |
| Designation |
Professor |
| Affiliation |
Jss Medical College and Hospital, Mysore, Karnataka |
| Address |
Department of Anaesthesiology,
Jss Medical College and Hospital,
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9845501226 |
| Fax |
|
| Email |
bpmanjula5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. BP MANJULA |
| Designation |
Professor |
| Affiliation |
Jss Medical College and Hospital, Mysore, Karnataka |
| Address |
Department of Anaesthesiology,
Jss Medical College and Hospital,
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9845501226 |
| Fax |
|
| Email |
bpmanjula5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jss Academy of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Jss Academy of Higher Education and Research |
| Address |
JSSAHER, Shivarathreeshwara Nagar, Mysore, Karnataka - 570015 |
| 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 R NANDHINI |
JSS MEDICAL COLLEGE AND HOSPITAL |
OPERATION THEATRE COMPLEX, 3RD FLOOR, JSS HOSPITAL, MYSORE, KARNATAKA
Mysore
KARNATAKA |
9489761919
nandhini_51@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
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 |
INTERVENTION |
NEBULISATION LIDOCAINE |
| Intervention |
INTERVENTION |
NEBULISATION MAGNESIUM SULFATE |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group of 18 years to 60 years
2. Patients belonging to American Society of Anesthesiologists grade 1 and 2 posted for surgery under general anaesthesia requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. History of allergy to the study drugs
3. Parturients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of magnesium sulfate and lidocaine on attenuation of intubation response. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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
|
Patients admitted to JSS hospital, undergoing elective surgery requiring general anaesthesia with endotracheal intubation, after applying inclusion and exclusion criteria, will be subjected to the study. Nebulization will be given with visira nebulizer mask, 30 minutes prior to induction and endotracheal intubation. Study parameters to be assessed are- 1. Hemodynamic changes observed at 0, 1, 3, 5, 10 minutes from time of intubation. 2. Incidence of postoperative sore throat. 3. Sedation in postoperative period |