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临床试验/CTRI/2023/10/058354
CTRI/2023/10/058354尚未招募3 期

Comparison of intravenous magnesium sulphate and intravenous lignocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in patients undergoing elective surgeries under general anaesthesia - A one year hospital based double blinded Randomised Clinical Trial

Dr Prabhakar Kore Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年10月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
To compare intravenous lignocaine with intravenous magnesium sulphate with respect to:

研究概览

简要总结

Laryngoscopy and endotracheal intubation are essential components of general anesthesia. 

But laryngoscopy results in stimulation of larynx, pharynx and trachea, which are extensively innervated by the autonomic nervous system, activation of which leading to various cardiovascular changes, dysrhythmias that may end up in stroke or cardiac arrest due to hemodynamic instability. 

Therefore, in recent times, it has become important to find an effective means of attenuating of sympathetic response to laryngoscopy and intubation and is one of the most researched topics in the field of anesthesiology.

Hesitation of using magnesium sulphate by anesthesiologists is seen although its efficacy is internationally proven and thus local data is deficient.

Thus, this study was designed to give a holistic view regarding the clinical importance of magnesium sulphate in blunting hemodynamic response to tracheal intubation during elective surgeries.

Therefore, aim of this study was to compare the hemodynamic stability during laryngoscopy with magnesium sulphate versus commonly used drug lignocaine in patients undergoing elective surgeries at a tertiary care center.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II
  • Patients undergoing elective surgeries under general anesthesia
  • Patients providing consent.

排除标准

  • Patients allergic to drugs under study
  • Patients with contraindication to general anesthesia
  • Patient refusal or who are unable to give consent
  • Patients undergoing emergency surgeries
  • Patients with significant cardiac and respiratory diseases
  • Patients with difficult airway
  • Pregnancy
  • Patients with oral and nasal pathology.

结局指标

主要结局

To compare intravenous lignocaine with intravenous magnesium sulphate with respect to:

时间窗: At baseline (before intubation), and at 1 min, 2 min, 3 min, 4min, 5min, 7 min, 10 min after intubation

Hemodynamic variables - Mean arterial pressure, Systolic blood pressure, Diastolic blood pressure, Heart rate

时间窗: At baseline (before intubation), and at 1 min, 2 min, 3 min, 4min, 5min, 7 min, 10 min after intubation

次要结局

  • Incidence of side effects & complications if any of the study drugs(From the time of administering the drugs till the end of the surgical procedure)

研究者

发起方
Dr Prabhakar Kore Hospital
申办方类型
Research institution and hospital

研究点 (1)

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