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临床试验/NCT07355049
NCT07355049尚未招募不适用

The Effect of Intravenous Dexmedetomidine Versus Intravenous Lidocaine on the Emergence Agitation After Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.

Fayoum University0 个研究点目标入组 80 人开始时间: 2025年12月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80

研究概览

简要总结

The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.

详细描述

Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient .

Early recovery from general anesthesia is accompanied by agitation, confusion, disorientation, and violent behavior, which is known as Emergence Agitation (EA). This post-anesthetic issue occurs in the early stages of General Anesthesia (GA) recovery, posing challenges in terms of both patient recovery delay and the complexities associated with assessment and management.

The incidence of EA varies, from approximately 0.25% to 90.5%, with age, assessment tool used, definitions, anesthetic techniques, type of surgery, and time of EA assessment during recovery .

Because the airway is contaminated with blood and the nasal airway is closed with surgical packs. ENT surgery is linked to a higher incidence of emerging agitation after nasal surgery.

Although EA is commonly self-limited and happens within the first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheters, physical damage, falling, increase in the risk of bleeding, and self-extubation .

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age : 18-60
  • ASA Physical Status I or II
  • Elective endoscopic sinus surgery under general anesthesia .

排除标准

  • Refusal to participate
  • Mental retardation or inability to communicate
  • Allergy to anesthetics or study medications .
  • Chronic use of beta blockers .
  • significant hepatic, neurologic, cardiovascular or respiratory disease .
  • BMI>35 kg/m2

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Eid Tolba Abo Elwa

Doctor

Fayoum University

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