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临床试验/NCT06466915
NCT06466915已完成4 期

Comparison of the Use of Propofol and Nasal Dexmedetomidine in the Management of Agitation and Delirium in Patients Undergoing Dental Procedures

Baskent University Ankara Hospital2 个研究点 分布在 2 个国家目标入组 162 人开始时间: 2024年7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
已完成
发起方
入组人数
162
试验地点
2
主要终点
Agitation-Delirium

研究概览

简要总结

Dental pain and anxiety are quite common in pediatric patients. However, due to children's inability to express their fears and lack of knowledge about the procedures to be performed, these symptoms have often been misunderstood and inadequately treated in pediatric settings. Children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia. Emergence anxiety can be harmful to the patient, leading to bleeding at the surgical site, displacement of intravenous catheters, parental anxiety, additional care needs, and delays in hospital discharge. Inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery. However, inhalation anesthetics often lead to a high rate of emergence anxiety, ranging from 25% to 80% depending on the scoring scale used, the child's age, and the type of surgery performed. Additional sedative or analgesic drugs, such as midazolam, dexmedetomidine, or propofol, have been used to prevent emergence anxiety.

Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects, but it can cause mild respiratory depression. Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs. It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression. However, although intranasal dexmedetomidine initially has relatively rapid absorption, the absorption process may take longer compared to intravenous administration, implying that the child's hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety.

The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice.

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, Investigator)

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Cardiac disease,
  • Psychiatric disease,
  • Coronary artery disease,
  • Long-term sedative drug use,
  • Pulmonary disease,
  • Known allergy to planned drugs

研究组 & 干预措施

Group PoDex

Experimental

Group PoDex received 0.5 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended and 0.5 mg/kg propofol IV before the extubation.

干预措施: Propofol (Drug)

Group Dex

Experimental

Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.

干预措施: Dexmedetomidine (Drug)

Group Pofol

Experimental

Group Pofol received 1 mg/kg propofol IV before the extubation.

干预措施: Propofol (Drug)

Group PoDex

Experimental

Group PoDex received 0.5 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended and 0.5 mg/kg propofol IV before the extubation.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Agitation-Delirium

时间窗: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.

It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.

Behavioral pain assessment

时间窗: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.

It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale.

次要结局

  • Nausea-vomiting(0, 5, 10, 15, 20, 25, 30. minutes after extubation.)
  • Rapid recovery(30 minutes after extubation.)

研究者

发起方
Baskent University Ankara Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Uslu

MD, Research assistant

Baskent University Ankara Hospital

研究点 (2)

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