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

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2024/07/070665
• Lead Sponsor: Datta Meghe Institute of Higher Education and Research

Brief Summary

The research investigates the efficacy of two pharmacological interventions, Esmolol and Magnesium Sulfate, in attenuating the hemodynamic stress response to laryngoscopy and endotracheal intubation. This randomized clinical trial involves patients aged 15 to 60 years, ASA I or II, undergoing elective ENT surgery. Participants are divided into two groups: one receiving Esmolol and the other receiving Magnesium Sulfate. Hemodynamic parameters are assessed at various time points throughout the peri-intubation period to evaluate the interventions’ effectiveness. Additionally, adverse events related to the interventions and perioperative management are monitored. The study aims to provide insights into optimizing perioperative care and enhancing patient safety during elective surgeries.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation	The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
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 procedures	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.

Trial Locations

Locations (1)

Datta Meghe Institute of Higher Education and Research; 🇮🇳 Wardha, MAHARASHTRA, India

Datta Meghe Institute of Higher Education and Research

🇮🇳Wardha, MAHARASHTRA, India

Dr Pavithra Konjety

Principal investigator

9422538005

pkonjety19@gmail.com