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临床试验/NCT05941767
NCT05941767已完成不适用

Comparing Intravenous Versus Nebulized Either Lidocaine or Dexmedetomidine for Attenuation of the Hemodynamic Responses to Laryngoscopy and Intubation

Zagazig University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in mean arterial blood pressure (MAP) in mmHg.

研究概览

简要总结

Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

详细描述

Hemodynamic responses to laryngoscopy and intubation are a significant concern for the anesthesiologist. Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. These hemodynamic derangements can be lethal in patients with multiple comorbidities. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The American Society of Anesthesiologists (ASA) physical status I & II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia.
  • Mallampati grade I, II

排除标准

  • Uncooperative patient. History of allergy to study drugs. Hemodynamically unstable patient. Renal or hepatic dysfunction or hypertensive patients.

研究组 & 干预措施

Dexmedetomidine nebulization

Active Comparator

The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) 20 minutes before induction.

干预措施: Dexmedetomidine nebulization (Drug)

Lidocaine Nebulization

Active Comparator

The patient will receive nebulized lidocaine 4% (3 mg /kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia.

干预措施: Lidocaine nebulization (Drug)

Dexmedetomidine IV

Active Comparator

The patient will receive an intravenous infusion of dexmedetomidine (1 ml= 4 mcg) via a syringe pump and will be started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.

干预措施: Dexmedetomidine IV (Drug)

Lidocaine IV

Active Comparator

The patient will receive 1.5mg/kg intravenous lidocaine 2% completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.

干预措施: Lidocaine IV (Drug)

结局指标

主要结局

Change in mean arterial blood pressure (MAP) in mmHg.

时间窗: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

Mean arterial pressure (MAP) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

Change in heart rate (HR) per minute.

时间窗: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

Heart rate (HR) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

Change in diastolic blood pressure (DBP) in mmHg.

时间窗: Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

Diastolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

Change in systolic blood pressure (SBP) in mmHg.

时间窗: Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation.

Systolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation.

Change in serum cortisol levels.

时间窗: Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation.

Base line blood sample will be drawn 45 minutes preoperative and 10 minutes post intubation for cortisol level measurements.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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