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临床试验/NCT05821972
NCT05821972招募中4 期

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月10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
招募中
入组人数
60
试验地点
1
主要终点
University of Michigan Sedation Scale (UMSS)

研究概览

简要总结

To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.

详细描述

Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.

The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with American Society of Anesthesiologists (ASA) physical status I & II who will be scheduled for cleft palate repair surgeries

排除标准

  • Parent refusal
  • Allergy to the study drugs
  • Suspected difficult airway
  • Patients with endocrine, renal, hepatic, and cardiac pathology
  • Psychiatric diseases
  • Asthmatic patients.

研究组 & 干预措施

Nebulized dexmedetomidine and ketamine

Experimental

Pre-operative nebulization of dexmedetomidine and ketamine

干预措施: Nebulization of dexmedetomidine and ketamine (Drug)

Nebulized dexmedetomidine

Active Comparator

Pre-operative nebulization of dexmedetomidine

干预措施: Nebulization of dexmedetomidine (Drug)

结局指标

主要结局

University of Michigan Sedation Scale (UMSS)

时间窗: Pre-operative

It ranges from 0 = awake, alert to 4 = unarousable

次要结局

  • Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)(Pre-operative)
  • Watcha scale for emergence delirium(Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.)

研究者

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

FATMA NABIL AHMED MOHAMED

Clinical Supervisor

Assiut University

研究点 (1)

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