| CTRI Number |
CTRI/2025/10/095852 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
What’s the Best Way to Use Lignocaine for Safer Tube Insertion During Surgery? A Comparison of Three Methods |
|
Scientific Title of Study
|
Comparing The Hemodynamic Effects Of Ultrasound Guided Transtracheal Lignocaine, Intravenous Lignocaine, Nebulized Lignocaine During Endotracheal Intubation – A Randomized 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 Prasanna Vadhanan |
| Designation |
HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 1,Department of Anesthesia,Vinayaka Missions Medical College and Hospital,keezhakasakudimedu,Kottucherry Post,Karaikal,Puducherry.
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stephen Anto S |
| Designation |
Junior Resident/ Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 1,Department of Anesthesia,Vinayaka Missions Medical College and Hospital,keezhakasakudimedu,kottucherry Post,Karaikal,Puducherry.
Karaikal
PONDICHERRY
609609
India |
| Phone |
8248629177 |
| Fax |
|
| Email |
stephenantosuresh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Stephen Anto S |
| Designation |
Junior Resident/ Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 1,Department of Anesthesia,Vinayaka Missions Medical College and Hospital,keezhakasakudimedu,kottucherry Post,Karaikal,Puducherry.
PONDICHERRY
609609
India |
| Phone |
8248629177 |
| Fax |
|
| Email |
stephenantosuresh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinayak Missions Medical College and Hospital |
| Address |
Department of Anesthesia,Vinayaka Missions Medical College and Hospital,Keezhakasakudimedu Post,Karaikal,Puducherry |
| 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 Stephen Anto S |
Vinayaka Missions Medical College and Hospital |
Department of Anesthesia,Vinayaka Missions Medical College and Hospital,keezhakasakudimedu,Kottucherry Post,Karaikal,Puducherry
Karaikal
PONDICHERRY |
8248629177
stephenantosuresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
Group A(Transtracheal Lignocaine) |
Patients will receive ultrasound-guided transtracheal lignocaine (2 ml of 4 percentage of lignocaine) 3 minutes before intubation. |
| Comparator Agent |
Group B(Intravenous Lignocaine) |
Patients will receive 2 percentage of intravenous lignocaine (1.5 mg per kg) 3 minutes before intubation |
| Comparator Agent |
Group C(Nebulized Lignocaine) |
Patients will receive 2 ml of 4 percentage of lignocaine nebulized 10 minutes before intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1,2 and 3
2. Patients scheduled for elective surgery under general anesthesia requiring endotracheal intubation
3. Modified Mallampati Class 1 or 2
|
|
| ExclusionCriteria |
| Details |
1. ASA physical status 3 or higher
2. Obese patients (BMI greater than 30)
3. Emergency surgery
4. Age less than 18 years or more than 60 years
5. Modified Mallampati Class 3 or 4
6. Known allergy to lignocaine
7. Patients with anticipated difficult airway
8. Duration of laryngoscopy exceeding 15 seconds
9. Anatomical abnormalities of the neck or anterior cervical region
10. Inability to identify the cricothyroid membrane on ultrasound
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the effects on hemodynamic response associated with laryngoscopy and intubation in these three groups.
2. To assess the incidence of tachycardia or hypertension during and immediately after intubation as a measure of sympathetic stress response.
|
1. Baseline (before induction)
2. After induction (before administration of study drug)
3. At intubation (0 minute)
4. 1, 3, 5 minutes after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/10/2025 |
| 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
|
This randomized controlled trial evaluates and compares the hemodynamic responses (heart rate, blood pressure changes) during endotracheal intubation when lignocaine is administered through three different routes: ultrasound-guided transtracheal injection, intravenous infusion, and nebulization.
Ninety adult patients (ASA I–II), scheduled for elective surgeries requiring general anesthesia with intubation, will be randomly assigned to one of the three groups. Each group will receive a standardized dose of lignocaine through one of the routes before intubation. Hemodynamic parameters will be recorded at baseline, during laryngoscopy, and at intervals after intubation.
The primary objective is to determine which route provides the most stable cardiovascular response during intubation.
Secondary objectives include assessing patient comfort, ease of administration, and incidence of adverse effects.
The study aims to guide anesthesiologists in selecting the optimal method of lignocaine administration to minimize the stress response and enhance patient safety during airway management. |