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临床试验/NCT07780760
NCT07780760招募中不适用

Effect of Preoprative Nebulized Dexmedetomidine Compared to Nebulized Lidocaine in Attenuating Sore Throat Following Tonsillectomy In Childern. A Prospective, Randomized, Double-Blinded Trial.

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年9月1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
招募中
入组人数
70
试验地点
1
主要终点
Incidence of Postoperative Sore Throat (POST)

研究概览

简要总结

The aim of the study is to compare the effect of nebulized Dexmedetomidine compared to nebulized Lidocaine on postoperative sore throat in childern undergoing Tonsillectomy.

详细描述

Tonsillectomy is one of the most commonly performed day-case surgeries in pediatric patients. Despite its routine nature, post operative sore throat (POST) remains significant cause of morbidity, leading to discomfort and reduced parental satisfaction(1) POST ranked sixth among the 10 most undesirable adverse effects related to general anesthesia (2). Irritation and inflammation of the airway caused by pressure exerted on the tracheal wall by the endotracheal tube (ETT)(3) trauma during intubation and mucosal dehydration(4) are thought to be the mechanistic basis for a postoperative sore throat (POST) During tonsillectomy, the shared surgical and anesthetic field poses a risk of airway manipulation, necessitating close cooperation between surgeon and anesthesiologist to maintain adequate oxygenation and a clear operative field(5) Intraoperative blood or fluid aspiration can further exacerbate upper airway irritation, contributing to POST(6) Given the impact of POST on patient well-being, effective preventive strategies are essential for optimizing postoperative recovery (7) Nebulization therapy is widely used to prevent POST. It is highly recommended because of small volume of drugs required for effect, easy way of administration, better patient compliance, and most importantly little risk of adverse events compared with other methods(such as gargle, intravenous, etc.)(8) Commonly used aerosolized drugs include corticosteroids, ketamine, magnesium, lidocaine, Non-steroidal anti-inflammatory drugs(NSAIDs), etc. and have achieved various effects(9_12) Previous studies showed promising results for both Nebulized Dexmedetomidine and Nebulized Lidocaine in Attenuating Sore Throat(13_14) , yet no study has directly compared the efficacy of Nebulized Dexmedetomidine Versus Nebulized Lidocaine in Attenuating Sore Throat Following Tonsillectomy.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Age: Childern between 3:15 years old
  • American Society of Anesthesiologists(ASA) Physical Status I or II
  • Elective Tonsillectomy

排除标准

  • Parents refusal
  • Presence of preoperative sore throat
  • Known allergy to the study drug
  • History of upper respiratory tract infection 2 weeks prior to surgery
  • Mental retardation or inability to communicate
  • Significant Cardiovascular disease as Heart Block
  • Post Tonsillectomy bleeding

研究组 & 干预措施

group D (Dexmedetomidine group)

Experimental

will recieve a dose of Dexmedetomidine 1 mcg/kg

干预措施: Group D (dexmedetomidine group) (Drug)

Group L (Lidocaine group)

Active Comparator

will recieve Lidocaine 2%, 1 mg/kg

干预措施: Group L (Lidocaine group) (Drug)

结局指标

主要结局

Incidence of Postoperative Sore Throat (POST)

时间窗: immediately on PACU

次要结局

  • Severity of sore throat (ST)(at the 4th postoperative hour)
  • *Hemodynamic Parameters(every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively)
  • Hemodynamic Parameters(every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively)
  • evaluation of other adverse effects(during the first postoperative hour.)

研究者

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

Mustafa Omar Rateb Abdelhafez

Doctor

Fayoum University Hospital

研究点 (1)

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