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Comparing Esmolol IV Infusion and 4% Lignocaine Nebulization for Minimizing Haemodynamic Changes during Laryngoscopy and Endotracheal Intubation: A Preoperative vs. Elective Surgery Study

Attenuation of Haemodynamic Responses to Laryngoscopy and Endotracheal Intubation (Before and Elective Surgery): A Comparative Study Between Intravenous Esmolol and 4% Lignocaine Nebulisation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070665
Enrollment
60
Registered
2024-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Administration of intravenous Esmolol at a dose of 1.5 mg/kg: Participants are administered intravenous Esmolol at a dose of 1.5 mg/kg. Esmolol, a selective beta-1 adrenergic receptor a

Sponsors

Datta Meghe Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants meeting specific criteria were included in the study. These criteria encompassed individuals aged between 15 to 60 years, falling within American Society of Anesthesiologists (ASA) physical status classification I and II, scheduled for elective Ear, Nose, and Throat (ENT) surgical procedures. Additionally, inclusion required participants to have provided valid informed consent, ensuring their understanding and willingness to participate in the study. These criteria aimed to establish a homogeneous participant group suitable for the investigation into the comparative efficacy of intravenous Esmolol and 4% Lignocaine nebulization in attenuating haemodynamic responses during laryngoscopy and endotracheal intubation.

Exclusion criteria

Exclusion criteria: Participants were excluded from the study if they did not meet the predefined inclusion criteria, including age, ASA status, and surgical type. Additionally, individuals with anticipated difficult intubation, uncontrolled hypertension or diabetes, a history of cardiac illness, neuromuscular disorders, hepatic disease, renal disease, known sensitivity to the drugs under investigation, cerebrovascular disease, or undergoing emergency surgery were excluded. Furthermore, patients with bronchial asthma or those currently receiving alpha and beta blockers were also excluded from participation. These exclusion criteria were established to mitigate confounding factors and ensure the safety and integrity of the study outcomes.

Design outcomes

Primary

MeasureTime frame
The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubationTimepoint: The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation

Secondary

MeasureTime frame
The secondary outcome of the study focuses on assessing the incidence of adverse events related to the study interventions and perioperative management. These adverse events may include hypotension, bradycardia, arrhythmias, or any other complications arising during the induction of anesthesia and endotracheal intubation proceduresTimepoint: This period begins from the administration of the study drugs (Esmolol or Magnesium Sulfate) and extends until the completion of the endotracheal intubation procedure. Adverse events are monitored continuously throughout this timeframe, allowing for the immediate identification and management of any complications that may arise during anesthesia induction and airway manipulation.

Countries

India

Contacts

Public ContactDr Amol SIngham

Datta Meghe Institute of Higher Education and Research

amol.anesthesia@dmiher.edu.in7020154259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026