| CTRI Number |
CTRI/2026/01/101404 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Different Ways of Giving Lignocaine to Reduce Heart Rate and Blood Pressure Changes During Breathing Tube Placement |
|
Scientific Title of Study
|
Comparative efficacy of different routes of administration of lignocaine
on hemodynamic stress response during endotracheal intubation- a
prospective randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul |
| Designation |
Secondary dnb- anaesthesia resident |
| Affiliation |
Bps gmc khanpur kalan, sonipat |
| Address |
Department of anaesthesia, BPS GMC khanpur kalan
Sonipat
HARYANA
131305
India |
| Phone |
9812555214 |
| Fax |
|
| Email |
doctor.rahul1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sarvesh |
| Designation |
Professor MBBS ,MD ( ANAESTHESIOLOGY) |
| Affiliation |
Bps gmc khanpur kalan, sonipat |
| Address |
Department of anaesthesia, BPS GMC khanpur kalan
Sonipat
HARYANA
131305
India |
| Phone |
9728800122 |
| Fax |
|
| Email |
sarv.mlb007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr prateek |
| Designation |
Assistant professor MBBS ,MD( ANAESTHESIOLOGY) |
| Affiliation |
Bps gmc khanpur kalan, sonipat |
| Address |
Department of anaesthesia, BPS GMC khanpur kalan
Sonipat
HARYANA
131305
India |
| Phone |
946278499 |
| Fax |
|
| Email |
neopatricks@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bps gmc khanpur kalan sonipat |
| Address |
Department of anaesthesia, Bps gmc khanpur kalan, sonipat,Haryana-131001 |
| Type of Sponsor |
Government 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 Rahul |
BPSGMC for women khanpur kalan sonipat |
Main otcomplex,BPSGMC for women khanpur kalan sonipat -131001,haryana
Sonipat
HARYANA |
9812555214
doctor.rahul1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BPS GOVT. MEDICAL COLLEGE FOR WOMEN KHANPUR KALAN sonipat Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous ,nebulized and topical
lignocaine spray |
1)Group IL will receive intravenous lignocaine 2% (1.5 mg/kg) 90 seconds before laryngoscopy.
2)Group NL will undergo nebulization with 4% lignocaine (1.5 mg/kg) over 10–15 minutes before induction.
3)Group SL will receive 10% lignocaine spray (1.5 mg/kg) applied to the oropharynx 5 minutes before induction.
|
| Intervention |
Lignocaine administration |
Different routes of administration of lignocaine during endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status I or II
2) Undergoing elective surgery under general anesthesia
3) Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
1) ASA grade III or above
2) History of allergy to lignocaine
3) Pregnant or lactating women
4) Patients with cardiovascular instability or conduction abnormalities
5) Respiratory tract infections, asthma, or COPD
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the most effective route of administration of lignocaine amongst the three (iv,nebulization,spray to oropharynx) , for mitigating hemodynamic stress response during endotracheal intubation |
Baseline, 1 minute, 3 minutes and 5 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate any adverse effects associated with each method of lignocaine administration.
. To evaluate the chemical markers for stress response –
1. CPK-MB
2. Serum lactate levels
|
Preoperative & post induction |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [doctor.rahul1994@gmail.com].
- For how long will this data be available start date provided 01-05-2027 and end date provided 01-05-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Airway management is a cornerstone of safe anesthetic practice.Among the techniques employed, direct laryngoscopy and endotracheal intubation remain the gold standard for securing the airway during general anesthesia.However, despite its widespread use and clinical effectiveness, this procedure stimulates a sympathetic response.The underlying mechanism is the intense nociceptive stimulation of the upper airway, including the pharynx, larynx, and trachea.This leads to activation of the sympathoadrenal axis, resulting in tachycardia, hypertension, increased intracranial and intraocular pressures and elevated myocardial oxygen demand, especially concerning in patients with underlying comorbidities such as ischemic heart disease or cerebrovascular disorders.The hemodynamic changes associated with laryngoscopy and intubation occur rapidly—within 5 seconds of laryngoscopy, peaking at around 1–2 minutes, and typically resolving within 5 minutes. During this period, however, substantial physiological disturbances may occur.Studies have reported that heart rate can increase by 20–25 beats per minute, blood pressure by as much as 50– 55 mmHg, and left ventricular ejection fraction may transiently fall by up to 20%. Over the years, multiple pharmacologic interventions have been employed to reduce the pressor response associated with intubation.These include opioids (e.g, fentanyl, alfentanil, remifentanil), vasodilators (e.g. nitroglycerine, nifedipine), beta-blockers (e.g, esmolol, labetalol), centrally acting alpha-2 agonists (e.g., clonidine, dexmedetomidine), magnesium sulphate, gabapentin, and local anesthetics such as lignocaine.Among these, lignocaine stands out due to its versatility, low cost, wide safety margin, and multiple routes of administration.Lignocaine acts by blocking voltage-gated sodium channels in neuronal membranes, thus inhibiting the initiation and propagation of nerve impulses.Lignocaine can be administered through three primary routes for airway anesthesia: Intravenous (IV): Systemically administered lignocaine has been shown to blunt sympathetic responses and reduce intraoperative awareness, but it has minimal local anesthetic effect on the airway mucosa. Nebulization (4%): This non-invasive technique distributes lignocaine aerosol throughout the airway, including the oropharynx, larynx, and proximal trachea, providing widespread mucosal anesthesia. Topical spray (10%): Offers rapid onset and localized anesthesia, typically applied to the posterior pharyngeal wall and laryngeal inlet. It is highly effective for short-term suppression of airway reflexes but may have limited reach in deeper structures. In the current study, we aim to evaluate and compare the efficacy of three commonly used methods of lignocaine administration—2% intravenous lignocaine, 4% nebulized lignocaine, and 10% topical lignocaine spray—in suppressing airway reflexes and mitigating hemodynamic responses during endotracheal intubation |