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临床试验/CTRI/2025/10/095852
CTRI/2025/10/095852尚未招募2/3 期

Comparing The Hemodynamic Effects Of Ultrasound Guided Transtracheal Lignocaine, Intravenous Lignocaine, Nebulized Lignocaine During Endotracheal Intubation – A Randomized Controlled Trial

Vinayak Missions Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年10月22日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1. To evaluate and compare the effects on hemodynamic response associated with laryngoscopy and intubation in these three groups.

研究概览

简要总结

This randomized controlled trial evaluates and compares the hemodynamic responses (heart rate, blood pressure changes) during endotracheal intubation when lignocaine is administered through three different routes: ultrasound-guided transtracheal injection, intravenous infusion, and nebulization.

Ninety adult patients (ASA I–II), scheduled for elective surgeries requiring general anesthesia with intubation, will be randomly assigned to one of the three groups. Each group will receive a standardized dose of lignocaine through one of the routes before intubation. Hemodynamic parameters will be recorded at baseline, during laryngoscopy, and at intervals after intubation.

The primary objective is to determine which route provides the most stable cardiovascular response during intubation. Secondary objectives include assessing patient comfort, ease of administration, and incidence of adverse effects.

The study aims to guide anesthesiologists in selecting the optimal method of lignocaine administration to minimize the stress response and enhance patient safety during airway management.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA physical status 1,2 and 3
  • Patients scheduled for elective surgery under general anesthesia requiring endotracheal intubation
  • Modified Mallampati Class 1 or 2.

排除标准

  • ASA physical status 3 or higher
  • Obese patients (BMI greater than 30)
  • Emergency surgery
  • Age less than 18 years or more than 60 years
  • Modified Mallampati Class 3 or 4
  • Known allergy to lignocaine
  • Patients with anticipated difficult airway
  • Duration of laryngoscopy exceeding 15 seconds
  • Anatomical abnormalities of the neck or anterior cervical region
  • Inability to identify the cricothyroid membrane on ultrasound.

结局指标

主要结局

1. To evaluate and compare the effects on hemodynamic response associated with laryngoscopy and intubation in these three groups.

时间窗: 1. Baseline (before induction) | 2. After induction (before administration of study drug) | 3. At intubation (0 minute) | 4. 1, 3, 5 minutes after intubation

2. To assess the incidence of tachycardia or hypertension during and immediately after intubation as a measure of sympathetic stress response.

时间窗: 1. Baseline (before induction) | 2. After induction (before administration of study drug) | 3. At intubation (0 minute) | 4. 1, 3, 5 minutes after intubation

次要结局

未报告次要终点

研究者

发起方
Vinayak Missions Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Prasanna Vadhanan

Vinayaka Missions Medical College and Hospital

研究点 (1)

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