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临床试验/NCT06215768
NCT06215768尚未招募早期 1 期

Comparative Study of Preoperative Intravenous Dexmedetomidine Versus Preoperative Intravenous Midazolam On the Incidence of Emergency Delirium in Pediatric Patients Undergoing Tonsillictomy and Adenoidectomy a Prospective Randomized Clincal Trial

Esraa Abdel Azez Soltan Mohamed Zayed0 个研究点目标入组 100 人开始时间: 2024年1月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
发起方
入组人数
100
主要终点
Emergency Delirium

研究概览

简要总结

Primary outcom Compare the effectiveness of study drugs on reducing the incidence of emergence delirium .

Secondary outcomes:

Sedation score Intensity of pain by FLACC Extubation time Iength of stay in Post anesthetic care unite (PACU ) Incidence of negative post operative behavioural changes (NPOBCs ) Laryngeospasm ny adverse effects

详细描述

Emergence delirium (ED) is a common neurologic complication that can not only distress children and their families in the early postanesthetic period, but can also have adverse effects on children in the long-term Emergence delirium (ED) is an acute confusion state during recovery from anesthesia; patients with ED may present with disorientation, hallucination, restlessness, and purposeless hyperactive physical behavior . ED is not fully equivalent to EA; ED can involve hypoactive signs or mixed forms and hyperactive signs similar to agitation . Nevertheless, the terms EA and ED have been used interchangeably in several studies Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of POED, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics.

Postoperative emergence delirium develops in 12% to 18% of all children undergoing general anesthesia for surgery.

dexmedetomidine, is a selective alpha-2 agonist, which works in the brain and spinal cord that has sedative, analgesic and anxiolytic properties. Dexmedetomidine also has the ability to lower the overall anesthetic requirements by reducing sympathetic outflow in response to painful surgical stimulation.

Midazolam is a widely used intravenous anesthetic agent with rapid onset, short duration of action and relatively rapid plasma clearance. It is mainly used to produce preoperative sedation and the induction of general anesthesia The action of midazolam can be explained through its action on gammaaminobutyric acid (GABA) receptors. GABA receptors mediate inhibitory neurotransmission in the central nervous system In our study we aim to compares the effectiveness of preoperative intravenous dexmedetomidine versus intravenous midazolam for the prevention of emergence delirium in pediatric patients undergoing tonsillectomy , adenoidectomy or both . .

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
Single (Investigator)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged 2-12 years
  • With ASA physical status 1 or 2
  • Who were scheduled for tonsillectomy with and without adenoidectomy under general anesthesia

排除标准

  • Emergency surgery
  • Intellectual disability
  • Neurological disease
  • Renal , hepatic, cardiac or respiratory disease
  • Allergy to the study drugs

研究组 & 干预措施

Dexemedetomidine group A

Experimental

Patients aged( 2_12) years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy will be randomized to receive intravenous dexmedetomidine 0.5 μg/kg

干预措施: Dexmedetomidine and Midazolam (Drug)

Midazolam group B

Experimental

Patients aged( 2_12) years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy will be randomized to receive intravenous midazolam 0.1 mg/kg

干预措施: Dexmedetomidine and Midazolam (Drug)

结局指标

主要结局

Emergency Delirium

时间窗: 30 minutes

The incidence of emergence delirium in pediatrics undergoing tonsillectomy and adenoidectomy a prospective randomised clinical trial .

次要结局

  • FLACC(30 minutes)

研究者

发起方
Esraa Abdel Azez Soltan Mohamed Zayed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esraa Abdel Azez Soltan Mohamed Zayed

Director

Assiut University

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