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临床试验/CTRI/2025/04/085710
CTRI/2025/04/085710尚未招募1 期

Comparison of intravenous magnesium sulphate versus dexmedetomidine in blunting of cardiovascular stress response following laryngoscopy and endotracheal intubation- A prospective randomised control study

Dr Kauvya K1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月12日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare the changes in hemodynamic parameters following laryngoscopy and endotracheal intubation after administration of magnesium sulphate and dexmedetomidine

研究概览

简要总结

Background: Laryngoscopy and endotracheal intubation are associated with a significant hemodynamic stress response leading to transient tachycardia and hypertension which may be detrimental to patients particularly with cardiovascular disease. Various pharmacological agents have been used to attenuate this stress response. This study aims to compare the efficacy of intravenous dexmedetomidine and magnesium sulphate in attenuation of cardiovascular stress response following laryngoscopy and endotracheal intubation

Methods: This prospective, randomized, double blinded study involving 100 patients aged 20-10 years of either gender classified as ASA 1 or 2, undergoing surgeries under general anaesthesia in PSG Institute of Medical Sciences and Research, Coimbatore. Participants are divided into 2 groups of 50 each based on computer generated randomization sequence. Group M - receive magnesium sulphate of dose 30mg/kg and Group D - receive dexmedetomidine of dose 0.75mcg/kg, administered before induction. Hemodynamic parameters including heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure are noted at baseline, 5,10 and 15 minutes since start of drug infusion, 30 seconds prior to laryngoscopy and at intervals 1,3,5 and 10 minutes post intubation

Conclusion: This study seeks to determine whether dexmedetomidine or magnesium sulphate more effective in attenuating the cardiovascular stress response during laryngoscopy and intubation. This finding will help guide anaesthetic management strategies, particularly in patients at risk of hemodynamic instability

研究设计

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

入排标准

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

入选标准

  • American society of anaesthesiologist class 1 & 2.

排除标准

  • 1.Pregnancy 2.Anticipated difficult airway 3.Unanticipated difficult airway requiring laryngoscopy time of more than 15 seconds 4.Obesity 5.Sinus bradycardia and any ECG abnormalities 6.Neuromuscular disorders 7.Allergic to study drug.

结局指标

主要结局

To compare the changes in hemodynamic parameters following laryngoscopy and endotracheal intubation after administration of magnesium sulphate and dexmedetomidine

时间窗: In surgeries under general anesthesia using endotracheal tube

Heart rate,systolic blood pressure, diastolic blood pressure, mean arterial pressure will be recorded at following time intervals

时间窗: In surgeries under general anesthesia using endotracheal tube

Baseline

时间窗: In surgeries under general anesthesia using endotracheal tube

5,10, and 15 minutes since the start of drug infusion

时间窗: In surgeries under general anesthesia using endotracheal tube

30 seconds before laryngoscopy and intubation

时间窗: In surgeries under general anesthesia using endotracheal tube

1,3,5,10 after intubation

时间窗: In surgeries under general anesthesia using endotracheal tube

次要结局

  • To assess the level of sedation using modified ramsay sedation score at 5,10,15 minutes since the start of drug infusion

研究者

发起方
Dr Kauvya K
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kauvya K

PSG Institute of Medical Science and Research

研究点 (1)

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