| CTRI Number |
CTRI/2025/10/095875 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Attenuation of laryngoscopic response in otorhinolaryngologic surgeries under general anaesthesia. |
|
Scientific Title of Study
|
A prospective randomised single-blind observational study to assess the effect of IV dexmedetomidine vs. IV esmolol and lignocaine combination for attenuation of laryngoscopic response in patients undergoing otorhinolaryngologic surgeries under 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 |
Kinal Vyas |
| Designation |
Resident Doctor |
| Affiliation |
GMERS medical college and hospital, Gotri, Vadodara |
| Address |
6th floor, Department of Anaesthesia, GMERS medical college and hospital, Gotri, Vadodara Vadodara GUJARAT 390021 India |
| Phone |
7016633701 |
| Fax |
|
| Email |
khvyas98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Santosh Dubey |
| Designation |
Associate Professor |
| Affiliation |
GMERS medical college and hospital, Gotri, Vadodara |
| Address |
6th floor, Department of Anaesthesia, GMERS medical college and hospital, Gotri, Vadodara, India
Vadodara GUJARAT 390021 India |
| Phone |
9825359853 |
| Fax |
|
| Email |
santosh19692001@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Santosh Dubey |
| Designation |
Associate Professor |
| Affiliation |
GMERS medical college and hospital, Gotri, Vadodara |
| Address |
6th floor, Department of Anaesthesia, GMERS medical college and hospital, Gotri, Vadodara, India
Vadodara GUJARAT 390021 India |
| Phone |
9825359853 |
| Fax |
|
| Email |
santosh19692001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GMERS medical college and hospital, Gotri, Vadodara, Gujarat, India-390021 |
|
|
Primary Sponsor
|
| Name |
GMERS medical college and hospital Gotri |
| Address |
GMERS medical college and hospital, Gotri, Vadodara, Gujarat, India-390021 |
| 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 |
| Kinal Vyas |
GMERS medical college and hospital, Gotri |
6th floor, department of anaesthesia, GMERS medical college and hospital, Gotri, Vadodara Vadodara GUJARAT |
7016633701
khvyas98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC, GMERS medical college and hospital, Gotri, vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV dexmedetomidine |
comparison of hemodynamic changes will be done while doing laryngoscopy both groups and evaluation of which group is better for attenuating the laryngoscopy response will be compared
dose of IV dexmedetomidine -1 mcg per kg |
| Comparator Agent |
IV esmolol and IV lignocaine |
comparison of hemodynamic changes will be done while doing laryngoscopy both groups and evaluation of which group is better for attenuating the laryngoscopy response will be compared
dose of IV esmolol and IV lignocaine -0.5 mg per kg and 1.5 mg per kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI less than 30 kg/m2
ASA 1-2
Pulse rate equal to or above 70/min with regular rhythm |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Allergic to study drugs
On chronic Medication for heart diseases like: AV Blocks, CHF, Brady-arrythmias, IHD, Hypertension.
Laryngoscopy time more than 20 seconds
Difficult bag and mask ventilation
Difficult intubation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Hemodynamic response that is pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure & rate pressure product at baseline, 1 minute, 3 minutes & 5 minutes after laryngoscopy |
To evaluate pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure & rate pressure product at baseline, 1 minute, 3 minutes and 5 minutes after laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note any adverse effects associated with drugs used in both the groups, any rescue medication needed for correction of over-attenuation of the response, such as use of sympathomimetic drugs |
To note any adverse effects associated with drugs used in both the groups, any rescue medication needed for correction of over-attenuation of the response, such as use of sympathomimetic drugs till the first 5 minutes of laryngoscopy & intubation |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
14/11/2025 |
| 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="0" 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
|
Laryngoscopy and endotracheal
intubation are integral components of general anaesthesia for airway
management. However, these procedures are associated with intense sympathetic
stimulation resulting in a transient but marked increase in heart rate and
blood pressure, collectively known as the pressor response or laryngoscopic
response. In patients with pre-existing cardiovascular conditions, this
response may precipitate myocardial ischemia, arrhythmias, or cerebrovascular
events. Hence, attenuating this hemodynamic response is critical for improving
perioperative safety and outcomes.
Several pharmacological agents have
been studied to mitigate the laryngoscopic response, including opioids,
beta-blockers, alpha-2 agonists, calcium channel blockers, and local
anaesthetics. Among these, dexmedetomidine, an alpha-2 adrenergic agonist, has
gained attention due to its sedative, analgesic, and sympatholytic properties.
It has been shown to blunt the stress response effectively while also providing
perioperative sedation and analgesia without significant respiratory
depression.
Esmolol, a short-acting
cardioselective beta-1 adrenergic blocker, is another commonly used agent to
suppress the tachycardia and hypertension associated with laryngoscopy. It has
a rapid onset and brief duration of action, making it particularly suitable for
short-term modulation of hemodynamics during induction and intubation.
Lignocaine, a local anaesthetic, when given intravenously, has been used to
suppress airway reflexes and blunt the pressor response due to its
membrane-stabilizing and antiarrhythmic effects.
While each of these
agents—dexmedetomidine, esmolol, and lignocaine—has demonstrated efficacy
individually in attenuating the laryngoscopic response, comparative studies are
essential to determine the most effective and safe option for clinical
practice. The choice of agent may depend on factors such as patient
comorbidities, drug onset and duration, side effect profiles, and anaesthetic
goals.
Out of all the 3 drugs,
dexmedetomidine (>esmolol >lignocaine) is found to be best for decreasing
the pressor response, but there are very few studies comparing dexmedetomidine
with combination of lignocaine and esmolol for attenuation of laryngoscopic
response. So we design this study to ascertain whether attenuation of
laryngoscopic response with combination of lignocaine and esmolol is comparable
or better than that caused by dexmedetomidine.
The findings may contribute to
optimizing anaesthetic management, particularly in patients at risk of
hemodynamic instability during airway manipulation. |