跳至主要内容
临床试验/CTRI/2024/07/070665
CTRI/2024/07/070665尚未招募不适用

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

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月8日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Investigator Blinded

入排标准

年龄范围
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation

次要结局

  • 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.)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Other []

研究点 (1)

Loading locations...

相似试验