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临床试验/CTRI/2025/12/098393
CTRI/2025/12/098393尚未招募4 期

Effect of Intravenous versus Nebulized Magnesium Sulphate on Hemodynamic response to Laryngoscopy and Intubation in Adult Patients undergoing Elective Surgery : A Comparative Study

Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年12月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
84
试验地点
1

研究概览

简要总结

Laryngoscopy and intubation are essential procedures in general anaesthesia for airway management and ventilation but can trigger sympathetic stimulation, leading to increased heart rate, blood pressure, arrhythmias, and elevated intracranial or intraocular pressure. Various pharmacological and non-pharmacological interventions have been explored to control these hemodynamic changes, but no optimal method has been established. Magnesium sulphate possesses anaesthetic, analgesic, and muscle relaxant properties, acting as a calcium antagonist, NMDA receptor blocker, and inhibitor of catecholamine release. It also induces vasodilation and has antiarrhythmic effects. Intravenous magnesium sulphate has shown efficacy in reducing the adverse hemodynamic response during intubation but may cause side effects such as hypotension, bradycardia, and respiratory depression. Nebulized administration provides better mucosal absorption, fewer systemic effects, and improved patient comfort. This study aims to compare nebulized and intravenous magnesium sulphate in attenuating the hemodynamic response to laryngoscopy, hypothesizing that the nebulized route is not inferior.

In this study, which is a randomized open label trial with a sample size of 84 that will be conducted in  Ramaiah Medical College, Bangalore, we aim to compare the  Effect of intravenous versus nebulized magnesium sulphate on hemodynamic response  to laryngoscopy and intubation in adult patients undergoing elective surgery.

The primary outcome of our study is to compare the HR and MAP following laryngoscopy  and intubation. Monitoring of HR and MAP occurs at specific time points: at baseline, at the time of  study drug administration, 5, 10, and 15 minutes after starting administration of the study drug, before induction, at the time of laryngoscopy, just after intubation, and 1, 5, and 10 minutes after  intubation. Secondary outcomes include the comparison of propofol consumption during the induction of anaesthesia, incidence of Post Operative Sore Throat, and any adverse effects of  magnesium sulphate, such as intraoperative bradycardia (HR 30 percentage fall from baseline, more than 20 percentage fall in  MAP from baseline), and postoperative nausea, vomiting, or respiratory depression.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Aged 18–65 years with American Society of Anaesthesiologists classification I-II Scheduled for elective surgery under general anaesthesia with endotracheal tube insertion.

排除标准

  • Anticipated difficult laryngoscopy and intubation Patient with cardiovascular dysfunction or arrythmias Hepatic or renal impairment Neuromuscular disorder Raised intracranial pressure or intraocular pressure Presence of preoperative oral ulcer, sore throat, pharyngitis Pregnant patients Patients allergic to magnesium sulphate.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Arpith A G

Ramaiah Medical College

研究点 (1)

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