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临床试验/NCT05694585
NCT05694585尚未招募4 期

Effect of Continuous Infusion of Esmolol on Perioperative Stress Reaction in Patients Undergoing Airway Intervention

Xiumei Song0 个研究点目标入组 46 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
46
主要终点
Changes in plasma norepinephrine levels

研究概览

简要总结

The goal of this clinical trial is to observe the effect of low dose continuous infusion of esmolol on perioperative stress response in patients undergoing airway intervention .

详细描述

Airway intervention is known to activate stress response and release catecholamines resulting in severe hemodynamic instability. Various techniques which are recommended to prevent the stress response include increasing the depth of anesthesia, improving surgical procedures and the use of various pharmacological agents. Esmolol blocks the action of the endogenous catecholamines, we plan low dose esmolol infusion decrease stress response and hemodynamic fluctuation during airway intervention.

46 patients scheduled airway intervention under general anesthesia were randomly divided into esmolol group and control group. esmolol 50μg/kg/min or saline 50μg/kg/min were iv administered before Operation beginning. If HR(heart rate)is greater than 90 beats/min, esmolol or saline 50μg/kg/min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication. Plasma level of Norepinephrine, epinephrine, and cortisol before induction of anesthesia and 30 minutes after beginning of operation were determined by high-performance liquid chromatography. Perioperative hemodynamics changes, extubation time, incidence of severe sinus bradycardia and bronchospasm were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

esmolol group

Experimental

esmolol group: esmolol 50 μg/kg /min were intravenously administered before Operation beginning. If HR(heart rate)is greater than 90 beats/min, esmolol 50μg/kg /min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication.

干预措施: Esmolol (Drug)

Saline solution

Placebo Comparator

Saline group: saline 50 μg/kg /min were intravenously administered before Operation beginning. If HR(heart rate)is greater than 90 beats/min, saline 50μg/kg /min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication.

干预措施: saline (Drug)

结局指标

主要结局

Changes in plasma norepinephrine levels

时间窗: up to 30 minutes after beginning of operation

level of Norepinephrine

Changes in plasma cortisol levels

时间窗: up to 30 minutes after beginning of operation

level of cortisol

Changes in plasma epinephrine levels

时间窗: up to 30 minutes after beginning of operation

level of epinephrine

次要结局

  • Hemodynamic changes :Heart rate(HR)(from anesthesia induction to 30 minutes after remove the laryngeal mask)
  • Laryngeal mask airway (LMA) removal time(Duration from the end of anesthetics infusion to LMA removal)
  • Hemodynamic changes :Diastolic blood pressure( DBP)(from anesthesia induction to 30 minutes after remove the laryngeal mask)
  • Hemodynamic changes :Systolic blood pressure(SBP )(from anesthesia induction to 30 minutes after remove the laryngeal mask)
  • Incidence of adverse reactions: Severe sinus bradycardia(from anesthesia induction to 30 minutes after remove the laryngeal mask)
  • Incidence of adverse reactions: bronchospasm(from anesthesia induction to 30 minutes after remove the laryngeal mask)

研究者

发起方
Xiumei Song
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiumei Song

Associate chief physician

Qianfoshan Hospital

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Effect of Esmolol on Perioperative Stress Reaction | 临床试验