Skip to main content
Clinical Trials/CTRI/2025/10/095875
CTRI/2025/10/095875
Not yet recruiting
Not Applicable

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.

GMERS medical college and hospital Gotri1 site in 1 country50 target enrollmentStarted: November 14, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
GMERS medical college and hospital Gotri
Enrollment
50
Locations
1
Primary Endpoint
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

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • BMI less than 30 kg/m2 ASA 1-2 Pulse rate equal to or above 70/min with regular rhythm.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
GMERS medical college and hospital Gotri
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Kinal Vyas

GMERS medical college and hospital, Gotri, Vadodara

Study Sites (1)

Loading locations...

Similar Trials